1. Biosimilar Battlegrounds
How originator companies face up to the biosimilar challenge
A Scrip Webinar presented by
Jessica Merrill and Eleanor Malone

2. Logistics
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A recording of this webinar and the slide deck will be sent to you.

3. About the Presenters Jessica Merrill
Eleanor Malone
Editor in Chief of Informa Pharma Insights Europe, overseeing Scrip, Pink Sheet, In Vivo and Generics Bulletin
Jessica Merrill
US-based Senior Editor for Scrip, Pink Sheet, In Vivo

4. Overview Originator firms on the front line of biosimilar competition
Key biologic brands facing competition
Extent of exposure for key firms
Defense tactics
US biosimilars landscape
European biosimilars landscape
Q&A

5. Those On The Front Line
Key Originator Companies with blockbuster biologicals whose market exclusivity has expired or will soon expire

6. Key Products Facing Biosimilar Competition
2017 Sales ($m)
2017 US Sales ($m)
2017 5EU Sales ($m)
Humira
18,427
12,361
4,147
Mabthera/Rituxan
7,500
4,194
1,392
Remicade
7,152
4,525
1,281
Herceptin
7,120
2,738
1,975
Avastin
6,789
2,938
1,641
Enbrel
7,885
5,206
1,167
Lantus
5,155
2,813
629
Neulasta
4,534
3,931
503
Humalog
2,865
1,717
402
Epogen/Procrit
2,068
1,771
152
Aranesp
2,053
1,114
470
Neupogen
549
369 77
TOTAL
68,808
43,677
13,836

7. Extent of exposure for key firms
Amgen
Johnson & Johnson
AbbVie
Roche

8. Projected Sales 2025 (change from 2017)*
Extent of Exposure: Amgen
Product
2017 Sales (change from 2016)
2018 Sales YTD
Projected Sales 2025 (change from 2017)*
Biosimilars
Enbrel (etanercept)
$5,433m (-9%)
$3,699m
$2,772m (-49%)
In US: Erelzi (Sandoz), launch delayed by patent case (Amgen claims 17 yrs of exclusivity from 2011). In EU: Benepali (Samsung Bioepis, approved 2016), Erelzi (Sandoz)
Neulasta (pegfilgrastim)
$4,534m (-2%)
$3,306m
$2,738m (-40%)
Mylan launched Fulphila in US in July Coherus’ Udenyca just approved.
Aranesp (darbepoetin alfa)
$2,053m (-2%)
$1,403m
$1,243m (-39%)
Epogen (epoetin alfa)
$1,096m (-15%)
$746m
$341m (-69%)
Retacrit (Pfizer) approved in US, May 2018, but not launched. First European biosimilar approved in 2007.
Neupogen (filgrastim)
$549m (-28%)
$290m
$344m (-37%)
In US: Zarxio (Sandoz) and Nyvestym (Pfizer). In EU, biosimilar filgrastim has been marketed for some years.
Total Product Sales
$21,795m (0%)
$17,517m
$26.5bn (+22%)
*Source: Datamonitor Healthcare

9. Extent Of Exposure: Amgen
Enbrel, Neulasta, Neupogen, Epogen are all facing biosimilar competition
Amgen is hedging by building its own portfolio of biosimilars, which is expected to be a key growth driver for the company in the coming years
Defending its brands with price concessions and where possible, lifecycle management strategies, like Neulasta Onpro.

10. Evolution of Sales To 2025 ($m)
Amgen Biosimilar Risk vs Portfolio Growth
Evolution of Sales To 2025 ($m)

11. Projected Sales 2025 (change from 2017)*
Extent of Exposure: Johnson & Johnson
Product
2017 Sales (change from 2016)
2018 Sales YTD
Projected Sales 2025 (change from 2017)*
Biosimilars
Remicade (infliximab)
$6,315m (-9.3%)
$4,088m
$3,648m (-42%)
Inflectra (Pfizer/Celltrion) and Renflexis (Merck/Samsung Bioepis) in US. Inflectra/Remsima, Flixabi (Samsung Bioepis), Zessly (Sandoz) in EU.
Procrit (epoetin alfa)
$972m (-12%)
$767m
$313m (-68%)
Stelara (ustekinumab)
$4,011m
$3,712m
$4,624m (+15%)
Expected in 2023/24 in US/EU
Total Pharma Product Sales
$36,256m (+8%)
$30,544m
$44.8bn
*Source: Datamonitor Healthcare

12. Projected Sales 2025 (change from 2017)*
Extent of Exposure: AbbVie
Product
2017 Sales (change from 2016)
2018 Sales YTD
Projected Sales 2025 (change from 2017)*
Biosimilars
Humira (adalimumab)
18,427
$15,018 (+10.3%)
14,930
Multiple biosimilars were launched in the EU in October Several firms have settlement agreements allowing launch of biosimilars in the US in 2023.
Total Pharma Sales
28,216
$24,428 (+19.5%)
47,646
*Source: Datamonitor Healthcare

13. Extent of Exposure: Roche
Product
2017 Sales ($m) (change from 2016)
2018 Sales YTD
Projected Sales 2025 (change from 2017)*
Biosimilars
Avastin (bevacizumab)
6,789 (-2%)
5,090 (+2%)
2,761 (-59%)
US expected in 2019: Mvasi (Amgen). EU expected 2022.
Herceptin (trastuzumab)
7,120 (+3%)
5,288 (+2%)
3,078 (-57%)
US expected 2019 with multiple entrants.
EU launched March 2018: Ontruzant (Samsung Bioepis).
Rituxan/Mabthera (rituximab)
7,500 (-1%)
5,092 (-9%)
2,805 (-63%)
Already launched in EU (Truxima: Mundipharma/ Celltrion launched 2017). Expected in US in 2019 after delays.
Total Pharma Product Sales
41,843 (+5%)
32,584 (+7%)
47,445 (+13%)
*Source: Datamonitor Healthcare

14. Defense Tactics
What can originator firms do to protect their top and bottom lines?

15. The Patent Thicket

16. Defense Tactics - Bundling, Rebates

17. Defense Tactics: Life Cycle Management Image source:
Amgen Neulasta Onpro promotional website
Defense Tactics:
Life Cycle Management

18. Defense Tactics
If you can’t beat ‘em, join ‘em – part 1

19. * When they go low, you go lower
Defense Tactics
If you can’t beat ‘em, join ‘em - part 2:
* When they go low, you go lower

20. Defense Tactics: Weaponize Patients
DTC campaigns in US
Europe less susceptible as no DTC advertising

21. Defense Tactics - Innovate
Optimise your R&D pipeline to replace expiring products
Next-generation product development
New technologies
Partnerships

22. Defense Tactics Round-up
Grow a Patent Thicket
Tie in customers with discounts, bundles, rebates
Life cycle management
Make/sell biosimilars
Compete on price
Target patients
INNOVATE!!

23. US and Europe

24. US and Europe: Two Very Different Biosimilar Markets
Around 50 biosimilars launched for drugs including:
Sanofi's Lantus (insulin glargine)
Amgen's Epogen (epoetin alfa)
Amgen/Pfizer's Enbrel (etanercept)
Amgen's Neupogen (filgrastim)
Amgen's Neulasta (pegfilgrastim)
Johnson & Johnson/Merck's Remicade (infliximab)
Roche's Rituxan (rituximab)
Roche's Herceptin (trastuzumab)
AbbVie's Humira (adalimumab)
Sandoz Zarxio (filgrastim)/
Amgen's Neupogen
Pfizer Inflectra (infliximab)/
J&J's Remicade
Merck Renflexis (infliximab)/
Mylan Fulphila(pegfilgrastim)/
Amgen's Neulasta
Pfizer Nyvestym (filgrastim)/
~50 biosimilars launched in Europe and 5 launched in the US

25. US Biosimilar Landscape

26. US Payers Expect To See Biosimilars Usurp Biologics
US and Europe: Two Very Different Biosimilar Markets
Payer Strategy
US Payers Expect To See Biosimilars Usurp Biologics
Pharmacy Benefit Managers Able & Prepared To Switch Patients to Biosimilars
”While they may not be interchangeable, biosimilars will be delivered to patients who today are on the branded product”
”Biosimilars are being included as a component of our 2017 standard formulary strategy replacing higher-costs drugs”
Timothy C Wentworth,
CEO, Express Scripts Holding Co
2017 JP Morgan Healthcare Conference
David M Denton,
CFO & EVP, CVS Health Corp
Company Analyst Day, 15 December, 2016

27. In The US, Mixed Biosimilar Success
In the US, biosimilar uptake has remained limited, but varies by category and is impacted by category-specific issues and general challenges like multiple payers, rebates, lack of interchangeability and physician/patient education.
Branded Remicade holds onto 93% share of infliximab market two years post biosimilar entry
-chronic medication, which leaves biosimilar market to new scripts
-J&J defensive contracting has blocked biosimilar infliximab from the market
-Pfizer lawsuit against J&J could impact contracting for biosimilars
Branded Neupogen only holds 37% share of filgrastim market three years post biosimilar entry
-acute treatment, so a steady flow of new patients
-administered in a cancer care setting in which patients often don’t know what brand they are receiving

28. A category in need of cheaper options
Insulin:
A category in need of cheaper options
Sanofi’s Lantus (insulin glargine) has been facing competition in the US from Eli Lilly/Boehringer’s Basaglar since 2015.
Sales of Lantus fell 19% in the first 9 months of 2018 to €2.7bn, with some of the decline offset by Sanofi’s newer glargine formula Toujeo.
In the US, Basaglar has performed well, though it was not approved as a biosimilar under US regulatory guidelines, but rather a complex small molecule. Basaglar generated $569m in the first nine months.
But the market could be restricted to just two products for now. Merck said it won’t launch its insulin glargine version, Lusdana.

29. Is Enthusiasm For Biosimilars Diminishing in the US?
Lackluster uptake of some early biosimilars is raising concerns drug developers might hit the pause on biosimilar development if momentum doesn't pick up.
-Mylan, early to biosimilars development, announced it is exploring strategic alternatives in August. Slow uptake of complex generics like Copaxone and biosimilars has been one challenge.
-Momenta said it is exiting biosimilar development to focus on novel drug development in October, pointing to the slow path to value creation and uncertainty in the market.
-Merck, in October, said it will not commercialize biosimilar version of Sanofi's insulin Lantus, after market assessment. Merck said it remains committed to biosimilars, however.
-Sandoz has abandoned its rituximab biosimilar in the US after the FDA called for another pivotal study.
-CRLS for biosimilars approved in Europe and elsewhere.

30. Payers Sound the Alarm in US
"If [the US market is] not able to produce movement … to the biosimilars and generate a return for those manufacturers that have gone down this biosimilar pathway and invested in those molecules I think they will just realize over time that they have to close up shop and move on. America would have missed a very significant opportunity."
Kaiser Permanente's national pharmaceutical contracting leader Ambrose Carrejo, 2017

31. Biosimilar Market: commentary on outlook
"Do they want to continue to benefit from monopoly rents today, or help generate a vibrant biosimilar market that can help reset biologic pricing – and drug pricing more generally – through competition. These are binary choices. You can't have your cake – or in this case, your rebates – and a vibrant market for biosimilar competition too."
Scott Gottlieb
speaking to US insurers at America's Health Insurance Plans (AHIP) National Health Policy Conference, March 2018

32. Signs of Life Tony Hooper
“Some of our competitors and public officials have made statements that the US biosimilar market is not working. We have a different point of view … The fact that a biosimilar now holds the majority share of [filgrastim] segment less than three years post-launch proves that biosimilars can find a meaningful place in the US market just as they have in Europe."
Tony Hooper
Amgen Former Exec VP-Global Commercial Operations

33. Give it time…
“We’re still in the infancy in the US” – Chrys Kokino, head of biologics for North America at Mylan
“If we look at what’s happened in Europe, what’s happened in other regulated markets, it’s a really bright future for the US.” – Mike Woolcock, senior VP at Apobiologix
“It’s an exciting time for biosimilars in the US today.” – Gary Deeb, senior VP global licensing and business development, Lupin Ltd.

34. Next up: Neulasta the next bellwether for US biosimilar uptake
Mylan launched Fulphila in July
Mylan priced aggressively lower versus the brand, a WAC of $4,175 per syringe, 33% discount to Neulasta WAC
Acute treatment administered in cancer care setting could result in more encouraging uptake
Still early days

35. European Biosimilar Landscape

36. More Products, Longer History
>50 launched biosimilars
Multiple molecules and competing products
Diversity of market type across Europe

37. Europe: Varied, But Tougher To Defend

38. Prospects For Originator Firms In Europe
Compete on price to share the market
Play to strengths in other areas:
Education and support
Logistics and inventory management
Delivery device and administration mode
Environmental impact of production
Focus on use of savings from biosimilars

39. A Turning Point For Humira
The first adalimumab biosimilars launched in Europe in October, all competing for a piece of AbbVie's $4.4bn in European revenues
It's the first time four biosimilars have launched at the same time, including Sandoz' Hyrimoz, Samsung Bioepsis/Biogen's Imraldi, Amgen's Amgevita and Mylan/Fujifilm Kyowa Kirin's Hulio and more on the way in 2019.
How will AbbVie defend its brand? Early signs suggest the company will be competing on price.
AbbVie has won one undisclosed tender for an 80% discount off the price of Humira

40. Eventually…
Biosimilars will take their place, even in the US, though it will be driven by European markets.
Some at the starting line may not stay the course, but big pharma’s presence in biosimilars could bring credibility to the market.
The speed and magnitude of price and market share erosion may be less painful for originators than some originally thought.
But eventually, biosimilar uptake is needed if global health care systems are going to be able to afford pharma’s next wave of innovative launches.

41. Questions?

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