As the biosimilar sector matures, what are the key issues that are shaping commercial strategies?
As physician and payer confidence in the use of biosimilars grows, US and European companies are having to rethink their go-to-market commercial strategies. Price is no longer the only driver and a hybrid approach is needed to forge new commercialisation strategies and partnerships. But what are the key reimbursement, physician education and regulatory obstacles that developers must take into account?
In this August 2019 report, Biosimilars: Go-to-Market Case Studies, US and EU experts explore, through case studies, how the changes in market dynamics, regulation, and payer perceptions are influencing the level of evidence, support and education that companies are investing to differentiate and improve the utilisation of their biosimilars.
Experts tackle key questions
- In terms of real-world data what are companies presenting to payers, healthcare professionals and patients and how influential is it?
- What additional education and patient support are companies providing to the clinical community to encourage biosimilar utilisation and improve the level of understanding?
- What role has competitive pricing strategies and drug rebates had on the uptake of biosimilars?
- How have the changes in regulatory guidelines on interchangeability impacted biosimilar access to the market?
- What role, if any, will partnerships and collaborations play in allowing biosimilar developers to develop a sustainable business model?
5 Case Studies included
- Humira biosimilars facing a litigious battle
- Biosimilar insulin–is it a sustainable business model?
- Roche oncology strategy–biosimilars versus next generation products
- Roche's RA franchise–is there room for tocilizumab biosimilars?
- Pegfilgrastim biosimilars provide a 33% discount and rely on a branded launch strategy
What our experts say…
"Do not focus on price alone. Companies should be extremely cautious in assuming it's all about the price. Prices can change dramatically, in an unpredictable way. Don't be overwhelmed by the hype of the US market, it's a huge and challenging market and to be successful you need to focus on what benefits the biosimilar brings to the patient and payers. It's also important to consider the organisational structure and how you can efficiently produce and supply the market as fast as possible in a sustainable way."
Head of Medical Affairs, Biosimilars and Generics (Europe)
"In general, biosimilar providers are not providing a lot of education or a lot of extra add on services. The packages that are being given are majorly driving the product, delivery and price. I think, there is room for education, for differentiation, and for more of a marketing play if you want. I also think there's a case to be made for targeting patients that so far have been on oral treatments, rather than a biologic. It's not easy, but may have additional market potential, rather than just competing for patients that have already been using biologics anyway."
Former Marketing Director, Leading Biotechnology Company (Europe)
"The Far East or emerging countries are starting to align their regulation polices and to look at reimbursement models and localising manufacturing process. The population outside of the US and Europe is significant and the health care burden is high. There's a social need for biosimilars to be there, we need to be part of that story."
Ian Henshaw, VP & Head of Global Biosimilar Unit, Biogen
"Some of the people that are working in the biosimilar space that I've spoken to recently are raising sustainability as a serious consideration. How sustainable is this market with some of the price erosion that you see? There's a lot of discussions around biosimilar [and generics] space and it isn't a nice space to be in if you're looking for a sustainable, long-term business. You have to come up with the latest and the greatest all the time. I think companies are learnings from the generics industry, if you look at the number of players today, they're significantly less, and the ones that you have are significantly bigger, with much more specialised type of capabilities than you would have seen 10 to 20 years ago."
Former Marketing Director, Leading Biotechnology Company (Europe)
What to expect
- A detailed report based on recent drug launches and withdrawals which analyses the commercial strategies companies are using to drive biosimilar usage
- An examination of 6 key issues and 5 case studies which developers can learn from and respond to
- 25 targeted questions put to experts
- Their perceptive responses that provide 42 insights supported by 176 directly quoted comments
Expert contributorsAll nine experts who contributed to this report have at least three years' experience in the development and/or commercialisation of biosimilars, or are considered experts in the field. The names of some contributors have been kept anonymous to ensure full and frank disclosure of opinion.
- Ian Henshaw, Vice President, Head of Global Biosimilar Unit, Biogen and Non-Executive Director, Samsung Bioepis. With over 26 years commercial experience in customer facing roles as well as significant project leadership through organisational change, he is trained and experienced in Lean Six Sigma techniques to optimise business and build new levels of performance and quality. He has been involved in the development of new businesses in the emerging markets and the launch of products in the US, Europe, and Asia.
- Miguel Forte, MD, PhD, CEO of Zelluna Immunotherapy. He is a pharmaceutical industry executive with 20 years professional activity in clinical, academic and pharmaceutical industry environments with documented experience in the management of operational and strategic functions across Research & Development, manufacturing, medical and general management
- Rakesh Dixit, PhD, DABT, President & CEO, Bionavigen, LLC, is a respected global leader known for building highly motivated safety assessment teams to advance small and large molecule biologics drug development programmes. He is a key opinion leader in Safety Assessment with proven experience in drug discovery, preclinical, and clinical development from IND/CTA, Phase I, II, III, BLA/MAA and approval. He has been a key contributor to the successful marketing approval of 10 marketed biopharmaceuticals and has successfully received approval of over 100 INDs and over 15 BLAs-NDAs.
- Anonymous Managing Director, Leading Biotechnology Company (Europe) with over 20 years' experience in product development, project management and business development as well as setup and development of expert teams. He has been responsible for the development and commercialisation of biosimilars, from early development to launch in the EU market in 2019. He has considerable expertise in management of R&D projects, regulatory affairs and business development for biosimilars.
- Anonymous Former Marketing Director, Leading Biotechnology Company (Europe) with 25 years pharma and biotech experience for companies with extensive business management experience from different therapeutic areas and geographies. Since 2017 he has been working as an independent advisor/consultant to the life science industry.
- Anonymous Head of Medical Affairs, Biosimilars and Generics (Europe) is a highly-qualified medical manager, with both a medical and commercial background. He has long experience in the pharma industry in a corporate environment on local and regional level, achievements in launch preparation, clearing legal pathway for biosimilar launch, medical communication for marketed biologics and developing medical affairs strategy for biosimilars.
- Anonymous Commercial Officer, Leading Biotechnology Company (Europe) is a highly accomplished commercial executive, deal maker and board advisor; with an established background in strategic business development and R&D operations. He has considerable experience of dealing with large multinational organisations and nimble private equity backed businesses.
- Anonymous Global Head, Commercial Biopharmaceuticals, Sandoz has more than 15 years of global pharmaceutical and generics industry experience. He has held several roles responsible for business-to-business commercialisation, market access, pricing, public affairs and health economics.
- Global Marketing Director, Leading Global Pharma Company (anonymous), with considerable experience in life sciences at global, regional and affiliate level. He has a strong track record in global and local strategy development with customer-focused execution. He has experience in both strategic and operational cross-functional leadership roles in Biologics, Rare Diseases, Specialty care, OTC and Medical Devices.
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