Source: GEN – Genetic Engineering & Biotechnology News The Top 15 Best-Selling Drugs of 2016 Source: GEN – Genetic Engineering & Biotechnology News 10.11.2018 г., BADI

The Top 15 Best-Selling Drugs of 2016 Trade Name/INN Indication 2016 2015 % Change  Humira® (adalimumab) Rheumatoid arthritis (RA); moderate to severely active polyarticular juvenile idiopathic arthritis; active psoriatic arthritis in adults; active ankylosing spondylitis in adults; moderate to severely active Crohn’s disease   $16.078 billion $14.012 billion  14.7% Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg)  indicated with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6 infection $9.081 billion $13.864 billion 34.5% Enbrel® (etanercept) Rheumatoid arthritis; polyarticular juvenile idiopathic arthritis in patients aged 2 years or older; psoriatic arthritis; ankylosing spondylitis; plaque psoriasis in patients aged 4 years or older $8.874 billion $8.697 billion 2.0% Rituxan® (rituximab, MabThera) non-Hodgkin’s lymphoma; chronic lymphocytic leukemia; rheumatoid arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely active RA who have inadequate response to one or more TNF-antagonist therapies; granulomatosis with polyangiitis (GPA) (Wegener’s granulomatosis) and microscopic polyangiitis (MPA) in adults in combination with glucocorticoids $8.583 billion $8.354 billion 2.7% 10.11.2018 г.

The Top 15 Best-Selling Drugs of 2016 Trade Name/INN Indication 2016 2015 % Change Remicade® (infliximab) moderately to severely active Crohn's disease in adults and children who have had an inadequate response to conventional therapy; reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adults with fistulizing disease; moderately to severely active ulcerative colitis in adults and children who have had an inadequate response to conventional therapy; moderately to severely active rheumatoid arthritis in adults (with methotrexate); moderate to severely active rheumatoid arthritis; active ankylosing spondylitis; active psoriatic arthritis; chronic, severe (extensive, and/or disabling) plaque psoriasis in adults who are candidates for systemic therapy, and when other systemic therapies are medically less appropriate $7.829 billion $8.760 billion 10.6% Revlimid® (lenalidomide) multiple myeloma, in combination with dexamethasone; multiple myeloma, as a maintenance therapy following autologous hematopoietic stem cell transplantation; transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities; mantle cell lymphoma in patients whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib  $6.974 billion $5.801 billion 20.2% Avastin® (bevacizumab) metastatic colorectal cancer with intravenous 5-fluorouracil–based chemotherapy for first-or second-line treatment; metastatic colorectal cancer, with fluoropyrimidine-irinotecan-or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line Avastin-containing regimen; nonsquamous 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 adult patients with progressive disease following prior therapy; metastatic renal cell carcinoma with interferon alfa; cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan in persistent, recurrent, or metastatic disease; recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer that is either platinum-resistant, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, or platinum-sensitive, in combination with carboplatin and paclitaxel, or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent. $6.752 billion $6.654 billion 1.5%

The Top 15 Best-Selling Drugs of 2016 Trade Name/INN Indication 2016 2015 % Change Herceptin® (trastuzumab) HER2 overexpressing breast cancer; HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma $6.751 billion $6.509 billion 3.7% Lantus® (insulin glargine) once-daily treatment for improving glycemic control in adults and pediatric patients with type 1 diabetes, and in adults with type 2 diabetes $6.054 billion $6.770 billion 10.6% Prevnar 13® / Prevenar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) prevention of pneumococcal pneumonia and invasive disease caused by 13 Streptococcus pneumoniae serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in adults aged 18 and older; prevention of invasive disease caused by the 13 serotypes in children ages 6–17; prevention of invasive disease caused by the 13 serotypes in children ages 6 weeks through 5 years old; prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in children ages 6 weeks through 5 years old $5.718 billion $6.245 billion 8.4% Xarelto™ (rivaroxaban)  reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; deep vein thrombosis (DVT) and pulmonary embolism (PE), and reduction in the risk of recurrence of DVT and of PE; prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery $5.390 billion $4.254 billion 26.7%

The Top 15 Best-Selling Drugs of 2016 Trade Name/INN Indication 2016 2015 % Change Eylea (aflibercept) novascular (wet) age-related macular degeneration; macular edema following retinal vein occlusion; diabetic macular edema (DME); diabetic retinopathy in patients with DME. $5.045 billion $3.977 billion 26.9% Lyrica® (pregabalin) peuropathic pain associated with diabetic peripheral neuropathy; postherpetic neuralgia; adjunctive therapy for adult patients with partial onset seizures; fibromyalgia; neuropathic pain associated with spinal cord injury $4.966 billion $4.838 billion 2.6% Neulasta / Peglasta (pegfilgrastim) and Neupogen / Gran (filgrastim) For both, decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia; and increasing survival in patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome or acute radiation syndrome). For Neupogen, additional indications of reducing time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML); reducing 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; mobilizing autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis; reducing 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. $4.701 billion $4.752 billion 1.1% Advair /Seretide (fluticasone and salmeterol) Advair Diskus indicated for asthma in patients aged 4 years and older; maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). Advair HFA indicated for asthma in patients aged 12 years and older. $4.325 billion $4.568 billion 5.3%