MP Group – Biosimilars Landscape – USA

A pleasure to share with you the second issue of the Biosimilars series from MP Group. This issue covers in-depth analyses of the US biosimilars outlook, which includes market dynamics, evolving regulatory and policy landscape, competitive analysis, etc.   

With 15+ biologics facing patent expiry by 2020, and ~25 more in the coming decade, ~$200+B biologics sales underpin the first wave of biosimilar opportunity, which is forecast to approach $500B around 2030. These high priced biologics contribute as much as one-half of healthcare inflation even as significant portion of the eligible patients cannot afford these treatments, even in the US. This landscape presents an enormous opportunity for biosimilars to treat many more if not all patients in need, multiplying today’s tiny volume many folds while ushering in at least a $20B opportunity within the decade.   

Biosimilars penetration lags in the US primarily due to delayed regulatory guidelines and marketplace hurdles created by the innovator companies. However, the tide is about to turn in favor of biosimilars as politicians, regulators, payors, and patients alike address these barriers in earnest.  The recent FDA interchangeability guideline emphasizes complete analytical and preclinical studies so that smaller PK/PD clinical studies to demonstrate bio-similarity, thereby obviating costly long term clinical studies to confirm safety and efficacy evaluation. The cost of developing a biosimilar is already down to double-digit millions of dollars from low triple digits and time it takes to filing is being cut into half.  The biosimilar development path for interchangeability designation is now practically clear, though real-world experience with the first hand-full of such approvals will help resolve remaining issues. In parallel, many initiatives are underway to tackle the originators’ tactics that have delayed adoption of biosimilars, though this will remain an iterative process until the second wave of biosimilars reaches the market. As the regulatory guidelines lead to substitutability as a norm, even with only a gradual improvement in market barriers, the competition will intensify.    

What will it take to succeed in this rapidly evolving biosimilars landscape?  A broader portfolio, thoughtful development strategy to manage costs, buyer and therapeutic focused commercial infrastructure are among the critical aspects to consider—along with creative collaborations to avoid duplication of efforts.    

Our active work enables us to maintain an in-depth understanding of this exciting opportunity, as many of our forecasts of the past decade are now being realized. We would be delighted to share our insights to help you advance your strategy, and look forward to your feedback.

Please download the second issue of the Biosimilars series. We would appreciate any queries/comments from your side.        

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