Over the next five years, the purchase and production of biosimilar drugs can expect to see double-digit growth. As biosimilar drugs become more widely produced, prescribed, used, and accepted, the competitive marketplace will continue to heat up. What are the drivers for biosimilar drug production? And what trends are having an impact on the industry? Here’s a look at today’s landscape — and a peek into what we can expect in the near future.
Trend: The Quest for Market Share
As the patents of blockbuster biologic drugs expire, there will be new opportunities for companies to use reference biologics to create biosimilar drugs. By 2020, $67 billion in biological patents will run out, including those for Lantus and Avastin, which collectively had over $8 billion in sales in 2013.
While some drug makers are in the process of or have already created biosimilars for popular biologics, they can’t be marketed until the patents expire. For example, Mylan and Momenta Pharmaceuticals are teaming to create a number of biosimilars that have complicated IP landscapes, which stand in the way of market entry for a decade or more. At stake for each biosimilar can be multi-billion dollar markets — which has not only pharmaceutical giants but also smaller, pure play companies fighting for the right to develop biosimilars.
Trend: The Case for Less Clinical Data
The strength of the CMC and comparative analytics package greatly influences the probability of approval for biosimilars. In accordance with the “totality of evidence” concept, strong CMC/analytical package will reduce the burden of proof on clinical data the first generation of biosimilars, which consist of molecules with lower molecular weights. Accordingly, biosimilar developers should embrace an optimized regulatory strategy, which suggests higher investment in CMC/comparative analytics and PK/PD bioequivalence studies as opposed to more challenging in-patient efficacy studies. This FDA stance of “totality of evidence” is fostering increased activity within the competitive landscape from smaller companies who believe that their proven, precise development methodologies will enable them to obtain biosimilar approvals for less money.
Trend: The quest for interchangeability
The introduction of the concept of interchangeability by the FDA has put the global success of the biosimilar market on hold. This is due to the FDA’s reluctance to issue formal guidance defining the approval pathway for interchangeable biologic. While this hold is happening, other countries with centralized, one payer systems are procuring biosimilar in large lots at the most advantageous quantities and costs. As a result, patients that are being treated for chronic diseases are receiving biosimilars from different manufacturers over the course of their treatment. The post-market data produced from these patients should provide more robust evidence than any designed and controlled clinical study. It will be interesting to see what happens first. Will the FDA will issue formal guidance on an approval pathway for interchangeable biologic or will the post-market data be so compeling that they will be forced to accept all biosimilars as interchangeable by default?
Over the next two to three years, we can expect it to be significantly easier to obtain approval for first generation biosimilars in the U.S. The faster drug developers can get biosimilars through the regulatory agencies, and as the cost to develop them decreases, the greater the opportunity will be for more companies to step in and have an impact on the industry. With more companies producing these drugs, there will be more options — and this means a greater number of people will be able to reap the benefits that biosimilars provide.