The Biologics Price Competition and Innovation Act (BPCIA) enacted in 2010 provides two abbreviated approval pathways for biological products (follow-on biologics). Developers of biologics can seek designation of their follow-on product as biosimilar to, or interchangeable with, a reference biological product approved by the Food and Drug Administration (FDA).
More than 13 years ago, Omnitrope (somatropin) received its approval in Europe on April 14, 2006. Since then, as of June 2019, 57 biosimilars from 15 different molecules have received greenlights, 27 of them in the last five years and 16 in the last year and a half. This acceleration is driven by the increasing need to generate savings that help keep pharmaceutical budgets under control. According to data from the consulting firm Fiercepharma, drugs approved in 2019 will generate sales of more than $20 billion in 2024.
Many of the doomsday scenario predictions for biosimilar competition if authorized biologics were to enter the space prematurely assume mainstream development and adoption of authorized biologics by innovator companies in the current market and do not take into consideration the outcomes seen over the past 18 years with authorized small molecule generics.
Once again, Congress has its eyes on the pharmaceutical industry. Legislators from both parties have been active in proposing new legislation that could impact biologics and the market for biosimilars in the United States. Although these proposed bills have taken a variety of approaches, they are principally focused on market access and pricing of biologic drugs.
Janet Woodcock’s recent comment on the state of pharmaceutical development,“It’s not working…,” should not surprise anyone. Her continuation, “and, it won’t work in the future," is the more surprising, and particularly troubling statement. What must we change?
In this second part of a two-part series, we’ll dive into some of the details and datasets behind pharmaceutical pricing, trends, and behaviors in an effort to move toward effective cost management, economic sustainability, and continued U.S. pharmaceutical innovation.
China’s biopharma segment has experienced double-digit growth for the past decade, and the landscape is poised for robust growth for the near future. The country's biopharma sales are on track to reach over $50 billion. Here's why that matters to you.
This is the second part of a two-part article exploring various types of prefilled syringes (PFSs) for biopharmaceutical products. Part 1 looked at needle-free and dual-chamber prefilled syringes. Part 2 examines the various aspects of prefilled syringes with staked-in needles and their impacts.
Biologicals are the next great step for the pharmaceutical industries. The double-edged sword is that, as the molecules become more and more complex, our need for control and understanding becomes greater.
At present, automatic substitution of biosimilars at a pharmacy level is not practiced in the EU5. Recent and future changes in the EU5 market access environment and regulatory landscape may favor automatic substitution, but implications on the biosimilar market are yet to be determined.
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