Biosimilars: Same Difference Grace Marable, PharmD, BCPS

Biosimilars: Same Difference Grace Marable, PharmD, BCPS
October 5, 2017 Biosimilars: Same Difference Grace Marable, PharmD, BCPS

I have no financial or non financial conflicts of interest to disclose.
Disclosure

Objectives Pharmacist: Define biological and biosimilar products
Evaluate the process by which biological products gain FDA approval Compare and contrast biosimilar licensed to date and those in the pipeline Technician: 1. Define biological and biosimilar products 2. Summarize how biological products are approved by the FDA 3. Review current and future biosimilar products

Biologic Medical product made from natural sources Example:
human, animals or microorganisms Example: Vaccinations ex: Prevnar 13Ⓡ, ZosterⓇ, influ Blood/blood products ex: hetastarch in NS Chronic migraine ex: BotoxⓇ (onabotulinumtoxinA) I have used the terminology biologicals, biosimilars and interchangeable and am going to define those in more detail. Biologics are medical products made from natural sources. Just like conventional medications, these products are intended to prevent, diagnose, treat and/or cure diseases or medical conditions. The first biological substance I found approval for on the FDA website was hetastarch in NS in It is a plasma volume expander used to treat hypovolemia.

Biosimilar Type of biological product that is licensed by the FDA
Biosimilars are a type of biological product approved by the FDA. Biosimilars are comparable to the biological product already FDA approved, AKA reference/originator product. The biosimilar will always be the second drug on the market for the indication and/or condition of the original approved reference product. Biosimilar development and approval by the FDA is based on the totality of Evidence. A manufacturer’s application for a bioisimilar product must include but is not limited to: analytical studies showing the biological product is “highly similar” to the reference product allowing minor differences in clinically inactive components, animal studies (to assess toxicity), and clinical study which must include assessment of immunogenicity and pharmacokinetics and dynamics to support safety purity and potency claims in at least 1 condition of use in which the reference product was approved for and the biosimilar is seeking approval for.

Biologic vs. Biosimilar
Biolosimilar Biologic All squares are rectangles, but not all rectangles are squares

So What? Biological products have become a large part of healthcare delivery in the United States. Even though they account for <1% of all prescriptions dispensed in the U.S., they constitute 28% of prescription-drug spending Bar graph- including older medications such as collagenase that were approved as far back as 1965 It is estimated by % of the New Drug Approvals will be some type of biologic

Legality Former President Barak Obama
Patient Protection and Affordable Care Act Biologics Price Competition and Innovation Act Regulatory pathway surrounding biologics all started in In 2010 there was a major shift in when a major shift in the way healthcare was attained by patients and performed/documented by health care professionals in our country. The Patient Protection and Affordable Care Act (Affordable Care Act), signed into law by President Obama on March 23, 2010, amended the Public Health Service Act (PHS Act) to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed (approved) biological product. This pathway is provided in the part of the Affordable Care Act known as the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

Characteristics of conventional medication vs. biologicals
Chemically synthesized Sugar, protein, nucleic acid, or combination Identifiable structure Not easily identifiable structure Stable Heat sensitive, microbial contamination Oral Injectable No Immune Response Potential Immune Response Brand/generic Reference drug/biosimilar/interchangeable First, lets distinguish several differences between conventional medications and biological medications. Conventional Drugs are chemically synthesized and have a known structure. For the most part these drugs are stable under a wide variety of temperatures. You can think of most oral agents as conventional and do not produce an immune response. Conventional drugs are branded and then generics follow once the brand has lost its patent time. Biologics may be composed of sugar, protein, nucleic acids or a combination of these substances and typically have a structure that is not easily identified. Biologics are sensitive to heat and susceptible to microbial contamination. Biologicals are injectable routes or may be infused. These drugs may produce an immune response in the patient. Biologicals produced first are considered the reference drug, then a biosimilar may come to market with a potential for interchangeability status from the FDA.

Manufacturing of conventional medication vs. biologicals
Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Chemical structure, synthetic, carbon copy Mixed structure, living cell, variability The manufacturing of these two groups are different and regulated by two different entities. The Center for Drug Evaluation and Research has authority and oversight of conventional drugs while the Center for Biologics Evaluation and Research has oversight over production of biologicals. Conventional drugs are synthetic and can be produced the same way each and every lot. The process is different for biologics since the drug is produced in a living cell. The process may be completed the exact same way lot to lot but variation may occur due to utilization of a living organism. ** I need an example McDonalds … Biologic examples: vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.

Interchangeability Biosimilar + additional standards ZERO
Interchangeable products are both biosimilar to an FDA-approved reference product, and can be expected to produce the same clinical result as the reference product in any given patient. An interchangeable product may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product. Interchangeables meet extra requirements: “An application for an interchangeable biological product also must include data or information to show that the proposed interchangeable biological product is expected to produce the same clinical result as the reference product in any given patient. In addition, for a product that will be administered more than once to an individual (as many biological products are), the application must include information that demonstrates that the risk in terms of safety or diminished effectiveness of alternating or switching between use of the proposed interchangeable product and the reference product is not greater than the risk of using the reference product without alternating or switching.” In September a :Statistical Approaches to Evaluate Analytical Similarity Draft was proposed with comments and

Audience Response Question #1
All of the following are pieces of clinical confirmation evidence the FDA reviews for a biosimilar product seeking FDA approval except? Efficacy Sterility Safety Immunogenicity

Purple Book Direct quote from website: Did You Know?
Using a color for the nickname of the list draws upon using "The Orange Book" to refer to "Approved Drug Products with Therapeutic Equivalence Evaluations". So during a meeting, a staff member said, "how about purple?" The use of bright colors aside, the Agency would like to emphasize that the Purple Book is not the biological equivalent of the Orange Book. The legal regimes governing the licensure of biologics and the approval of drugs are different, and the Purple and Orange Books reflect these differences.

Purple Book September 2014 published on FDA website
Date on which the product was licensed under section 351(a) of the PHS Act. Whether FDA evaluated the product for reference product exclusivity. Whether the product has been determined to be biosimilar to or interchangeable with a reference product (i.e., a previously licensed biological product).

Pharmacist Guidance- AR Board of Pharmacy
REGULATION 7—DRUG PRODUCTS/PRESCRIPTIONS 07-00: GENERAL REGULATIONS REGARDING DRUGS/PRESCRIPTIONS biological product biosimilar biosimilar product interchangeable biological product : GENERIC AND BIOLOGICAL SUBSTITUTION substitute product that are interchangeable biological products Regulation 7, which describes drug products/prescriptions was recently updated : General Regulations regarding drugs/prescriptions is now updated with definitions to match FDA definitions and glossary terms to add definitions of biological product, biosimilar, biosimilar product, and interchangeable biological product. Other language clarified is in regards to pharmacist’ ability to substitute products which are interchangeable biological products.

Nonproprietary Naming of Biological Products
Biological: core name Biosimilar: core name-wxyz Ex: infliximab (RemicadeⓇ) infliximab-abda (RenflexisⓇ) infliximab-dyyb (InflectraⓇ) For originator biological products, FDA uses a core name submitted by the drug company which is reflective of the chemical structure and/or pharmacological properties. For a related biological product, a biosimilar product, or an interchangeable product, the core name will be the same as originator biological product including a distinguishing suffix that is devoid of meaning and composed of four lowercase letters will be attached with a hyphen to the core name of each originator biological product. A submission of 10 different options must be submitted for review by the FDA. The proposed suffix should: • Be unique • Be devoid of meaning • Be four lowercase letters of which at least three are distinct • Be nonproprietary • Be attached to the core name with a hyphen • Be free of legal barriers that would restrict its usage The proposed suffix should not: • Be false or misleading, such as by making misrepresentations with respect to safety or efficacy • Include numerals and other symbols aside from the hyphen attaching the suffix to the core name • Include abbreviations commonly used in clinical practice in a manner that may lead the suffix to be misinterpreted as another element on the prescription or order • Contain or suggest any drug substance name or core name • Look similar to or be capable of being mistaken for the name of a currently marketed product (e.g., should not increase the risk of confusion or medical errors with the product and/or other products in the clinical setting) • Look similar to or otherwise connote the name of the license holder • Be too similar to any other FDA-designated nonproprietary name suffix

Currently Approved Biosimilars
5 biologics with an approved biosimilar 3/6/2015- was first biosimilar to receive a licensure Adalimumab Bevacizumab Etanercept Filgrastim Infliximab

adalimumab Non Proprietary Name Proprietary Name Approval Date
Drug company Biosimilar adalimumab HumiraⓇ 12/31/2002 AbbVie adalimumab-atto AmjevitaⓇ 9/23/2016 Amgen B adalimumab-adbm CyltezoⓇ 8/25/2017 Boehringer Ingelheim

Indications adalimumab adalimumab -atto adalimumab-adbm
Rheumatoid Arthritis yes Psoriatic Arthritis Plaque Psoriasis Crohn’s Disease Pediatric Crohn’s Disease no Ulcerative Colitis Hidradenitis Suppurativa Ankylosing Spondylitis Juvenile Idiopathic Arthritis Non Infectious Uveitis

adaliumab-atto Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: A randomized, double-blind, multicenter, phase III study Objective: efficacy and safety of ABP 501 with adalimumab Primary Endpoint: clinical similarity in Psoriasis Area and Severity Index (PASI) percent improvement from baseline to week 16

adalimuab-atto Will not come to US market until January 31, 2023 due to patent litigation results. Papp, K.. Journal of the American Academy of Dermatology, 76(6), doi: /j.jaad

bevacizumab Non Proprietary Name Proprietary Name Approval Date
Drug Company Biosimilar bevacizumab AvastinⓇ 2/26/2004 Genentech bevacizumab- awwb MvasiⓇ 9/14/17 Amgen/Allergen B First oncological biosimilar

Indications bevacizumab bevacizumab-awwb Metastatic colorectal cancer, with 5FU-based chemotherapy for first or second-line treatment yes Metastatic colorectal cancer, with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen Non-squamous non-small cell lung cancer, with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease Glioblastoma, as a single agent for patients with progressive disease following prior therapy Cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan in persistent, recurrent or metastatic disease Metastatic renal cell carcinoma with interferon alfa Recurrent epithelial ovarian, fallopian tube, or primary perinatal cancer that is platinum resistance in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan, platinum sensitive in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine followed by bevacizumab as a single agent no Bevacizumab is approved for 5 types of cancer but is not approved for recurrent epithelial ovarian, fallopian tube or primary perinatal cancer that is platinum resistant with the following oncology therapies

etanercept Non Proprietary Name Proprietary Name Approval Date
Drug Company Biosimilar etanercept EnbrelⓇ 11/2/1998 Amgen etanercept-szzs ErelziⓇ 8/30/2016 Sandoz B

Indications etanercept etanercept-szzs Rheumatoid arthritis yes
Polyarticular Juvenile Idiopathic Arthritis (JIA) in patients aged 2 years or older Psoriatic Arthritis Ankylosing Spondylitis Plaque Psoriasis

Egality study The Egality study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis Objective: to demonstrate equivalent efficacy, and comparable safety and immunogenicity of GP2015 and the etanercept originator (ETN, Enbrel) in patients with moderate-to-severe plaque-type psoriasis Primary endpoint- PASI 75 response rate after the first 12 weeks of treatment PASI 75 response rate- refers to proportion of patients showing >75 % improvement in PASI score from baseline visit)

Egality study Figure 1. Egality study design. ETN, etanercept originator product.

Egality study Figure 4.(a) Percentage change from baseline in Psoriasis Area and Severity Index (PASI) score until week 12 (per protocol set).

filgrastim Non Proprietary Name Proprietary Name Approval Date
Drug Company Biosimilar filgrastim NeupogenⓇ 2/20/1991 Amgen filgrastim-sndz ZarxioⓇ 3/6/2015 Sandoz B tbo-filgrastim

Indications filgrastim filgrastim-sndz
Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever yes Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) no The only indication the biosimilar is not approved for is the exposure of myelosuppressive doses of radiation

PIONEER study Comparison of EP2006, a filgrastim biosimilar, to the reference: a phase III, randomized, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy Objective: assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients Primary Endpoint: Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy Cycle 1 is 21 days Grade 4 neutropenia is defined as mean number of consecutive days with ANC 0.5 x 10 to the 9th cells/L

PIONEER study

PIONEER study Mean DSN for the PP set was 1.17 ± 1.11 days in the biosimilar (N = 101) and 1.20 ± 1.02 days in the reference arm (N = 103). Mean treatment difference was 0.04 days with lower limit of the 97.5% CI of −0.26 days. Biosimilar was noninferior to the reference, because the lower bound of the 97.5% CI was entirely above the predefined noninferiority margin of −1 day.

infliximab Non Proprietary Name Proprietary Name Approval Date
Drug Company Biosimilar infliximab RemicadeⓇ 8/24/1998 Janssen infliximab-dyyb InflectraⓇ 4/5/2016 Pfizer B infliximab-abda RenflexisⓇ 4/21/2017 Merck

Indications infliximab infliximab-dyyb infliximab-abda Crohn’s Disease
yes Pediatric Crohn’s Disease Ulcerative Colitis Pediatric Ulcerative Colitis no Rheumatoid Arthritis in combination with methotrexate Ankylosing Spondylitis Psoriatic Arthritis Plaque Psoriasis

Nor-Switch Trial A Randomized, double-blind, parallel- group study to evaluate the safety and efficacy of switching from innovator infliximab to biosimilar infliximab compared with continued treatment with innovator infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis Objective: assess the safety and efficacy of switching from Remicade to the biosimilar treatment Remsima in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and chronic plaque psoriasis Primary Endpoint: Disease worsening during 52 week follow up Disease worsening was defined as disease specific composite measures of a consensus about disease worsening between investigator and patient leading to major change in treatment.

Nor-Switch Trial Patients were included only if they had been receiving the originator infliximab for at least 6 months Figure 1. Trial Profile

Nor-Switch Trial Patients continued on the same therapy from Week 0 to Week 52 had a similar percentage of disease worsening. Both arms of the study showed disease worsening at a similar point in the study. It didn’t matter which treatment option was administered. Both groups had decrease.

Nor-Switch Trial Based on disease state being evaluated for change in disease specific composite measures varying scales and indexes were used to compare originator infliximab vs. biosimilar throughout the 52 week study period. Blue is originator and red is biosimilar. Bars represent 95% CI from a mixed model adjusted for baseline value. Figure 3. Change in disease-specific composite measures during 52 weeks of follow-up in the per-protocol set.

SB2 infliximab trial A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy Objective: compare the efficacy, safety, immunogenicity and pharmacokinetics of SB2 to the infliximab reference product in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy Primary Endpoint: American College of Rheumatology 20% response at week 30 RA for at least 6 months and treated with methotrexate for at least 6 months

SB2 infliximab trial

Audience Response Question 2
How many biologics currently have an approved biosimilar? 2 3 4 5

Currently Approved Interchangeables
ZERO

A Comparison of PF708 and ForteoⓇ in Osteoporosis Patients
Future Biosimilars Start Date Trial Est. Completion December 2016 A Comparison of PF708 and ForteoⓇ in Osteoporosis Patients June 2018 February 2015 A Study Comparing LBEC0101 to EnbrelⓇ in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy March A Study to Evaluate the Long-term Safety and Efficacy of LBEC0101 in Subjects With Active Rheumatoid Arthritis Despite Methotrexate (MTX) Forteo=teriperatide Enbrel=etanercept

Reimbursement HCPCS codes J Code Q Code Permanent billing code
Ex: J1745 Injection, infliximab, excludes biosimilar, 10 mg Q Code Temporary billing code Ex: Q5102 Injection, infliximab-dyyb, biosimilar, 10 mg, ZB (Pfizer) Ex: Q5102 Injection, infliximab-abda, biosimilar 10 mg, ZC (Merck/Bioepis) Biosimilars can potentially be a benefit to a formulary budget or cost savings initiatives. Many first generation biologics are getting close to the end of their patent. Most biologics receive a 12 year patent from date of approval. As more biosimilars are approved, competition in the market will increase and hopefully that competition will decrease prices of these expensive medications. While keeping this in mind you want to make sure you have the right HCPCS code assinged to the medication. A J code wil be the permanent code assigned to the drug but until a J Code is assinged a Q code will be assigned and this will be the temporary code. CMS will group biosimilar products that rely on a common reference product’s biologics license application into the same payment calculation, and these products will share a common payment limit and HCPCS code. A modifier is assigned to biosimilars with the same hcpcs code to determine the manufacturer.

Audience Response Question #3
Which of the following biosimilars has all of the same FDA approved indications as its originator? adalimumab etanercept filgrastim infliximab

Food for Thought Physician Education Billing and Reimbursement
Information Technology Order Sets Prior Authorization and Patient Assistance Programs -biologics are from cell line that can differ slightly in the non active ingredients (but not clinically different in outcomes) -Q codes have been loaded to the Medicaid list -Information Technology Specialist (help with the new drug build record and assign the correct billing code and units) -Do you have the previous biologic on an orderset? Potentially have the biologic ordered but the biosimilar get dispensed and administered. With barcode technology this shouldn’t happen but there are workarounds and it is important to check all orders/ordersets for accurate medications. -If you are over a setting which will provide and/or administer these medications it is important to get someone from admissions/appointments is checking for a Prior Authorization and that the patient is enrolled in the correct Patient Assistance Programs. If you are tranisitioning the patient from the biologic to the biosimilar more than likely the patient was enrolled in a patient assistance program due to the cost of the medication. Even with insurance the copay can be costly. Double checking on this for the patient can be a big help to relieve cost burden of the drug. -Lastly if there is someone in decision support or financial department who can help build a report to keep an eye on these patients you would want to look into this as well. This way you can see if you are receiving payment and what type of payment from certain insurance companies.

References AMJEVITA® (adalimumab-atto) injection for subcutaneous use. Initial U.S. Approval: (2016, September). Retrieved August 23, 2017, from AVASTIN® (bevacizumab) Solution for intravenous infusion Initial U.S. Approval: (2014, October). Retrieved August 16, 2017, from Biosimilars - Information for Healthcare Professionals (Biosimilars). (n.d.). Retrieved July 20, 2017, from Center for Biologics Evaluation and Research. (n.d.). About the Center for Biologics Evaluation and Research - What Are. Retrieved August 5, 2017, from Center for Drug Evaluation and Research. (n.d.). Biosimilars - Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations. Retrieved July 23, 2017, from Center for Drug Evaluation and Research - List of Licensed Biological Products with (1) Reference Product Exclusivity and (2) Biosimilarity or Interchangeability Evaluations to Date. (2017, September 14). Retrieved September 26, 2017, from Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry. (2017, January 17). Retrieved September 9, 2017, from CYLTEZO® (adalimumab-adbm) injection, for subcutaneous use Initial U.S. Approval: (2017, August). Retrieved September 5, 2017, from Davies, N. (2017, March 7). The FDA's take on Biosimilars. Retrieved September 11, 2017, from Enbrel® (etanercept) Solution for Subcutaneous Use Initial U.S. Approval: (n.d.). Retrieved August 10, 2017, from ERELZI® (etanercept-szzs) injection, for subcutaneous use Initial U.S. Approval: (n.d.). Retrieved August 10, 2017, from Griffiths, C., Thaçi, D., Gerdes, S., Arenberger, P., Pulka, G., Kingo, K., Afonso, M. (2017). The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis. British Journal of Dermatology, 176(4), doi: /bjd.15152 HUMIRA® (adalimumab) Injection, Solution for Subcutaneous use Initial U.S. Approval: (2011, December). Retrieved August 23, 2017, from

References INFLECTRAⓇ (infliximab-dyyb) for Injection, for Intravenous Use Initial U.S. Approval: (2016, April). Retrieved July 8, 2017, from Jørgensen , K., Olsen, I., Goll, G., Lorentzen, M., Bolstad, N., Haavardsholm, E., Kvien, T. (2017, May 11). Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Retrieved September 17, 2017, from Kiran Panesar, BPharmS (Hons), MRPharmS, RPh, CPhFreelance Medical WriterOrlando, FloridaConsultant PharmacistNordic Medical CentreAddis Ababa, Ethiopia. (2016, October 14). Biosimilars: Current Approvals and Pipeline Agents. Retrieved July 29, 2017, from Maxwell, A. (2014, October 20). Purple Book Launches New Chapter in Generic Drugs. Retrieved September 20, 2017, from MVASI® (bevacizumab-awwb) Solution for intravenous infusion. (2017, September). Retrieved September 29, 2017, from NEUPOGEN® (filgrastim) injection, for subcutaneous or intravenous use Initial U.S. Approval: (2015, February). Retrieved August 7, 2017, from Papp, K., Bachelez, H., Costanzo, A., Foley, P., Gooderham, M., Kaur, P., Strober, B. (2017). Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: A randomized, double-blind, multicenter, phase III study. Journal of the American Academy of Dermatology, 76(6), doi: /j.jaad REGULATION 7—DRUG PRODUCTS/PRESCRIPTIONS. (2014, December 29). Retrieved August 14, 2017, from REMICADE® (infliximab) Lyophilized Concentrate for Injection, for Intravenous Use Initial U.S. Approval: (2013, November). Retrieved July 9, 2018, from RENFLEXISⓇ (infliximab-abda) for Injection, for Intravenous Use. (2017, April). Retrieved August 8, 2017, from Smits, L. J., Derikx, L. A., Jong, D. J., Boshuizen, R. S., Esch, A. A., Drenth, J. P., & Hoentjen, F. (2016). Clinical Outcomes Following a Switch from Remicade® to the Biosimilar CT-P13 in Inflammatory Bowel Disease Patients: A Prospective Observational Cohort Study. Journal of Crohns and Colitis, 10(11), doi: /ecco-jcc/jjw087 ZARXIO® (filgrastim-sndz) Clinical, Administration, and Pricing Overview. (2017, April). Retrieved August 7, 2017, from ZARXIO™ (filgrastim-sndz) injection, for subcutaneous or intravenous. (15, March). Retrieved August 7, 2017, from

Questions Grace Marable, PharmD, BCPS
Pharmacy Director/Clinical Coordinator Baptist Health Medical Center - North Little Rock 3333 Springhill Drive North Little Rock, Arkansas 72117 Phone:

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