Biosimilars: Like Ryan Reynolds and Ryan Gosling
The FDA describes a biosimilar as a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, that has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products. Arguably very similar to the two Canadians featured in the title.
As of December 5th, 2016, the EMA had approved 23 biosimilars. The first was in 2006, Omnitrope, produced by Sandoz. In contrast the FDA has only approved four biosimilars, the first in March 2015, almost ten years behind Europe.
While a biosimilar may require fewer clinical trials than the reference product to gain approval, it may require greater analytical characterization, and nonclinical and clinical pharmacology data. The FDA doesn’t require comparative analysis between two biosimilars, only against the reference product. When the FDA grants biosimilar approval, it is not automatically considered interchangeable with its reference product. In fact, none of the FDA approvals hold interchangeable status.
Many leading biologics are facing patent expiration around the world, so the biosimilar market is expected grow during 2016 to 2024. The PharmSource Lead Sheet easily allows the user to identify biosimilars in any API search tab. You can chart the activity over time using the Trend Reports feature, check the current pipeline over any date range or see a geographical spread of companies developing these drugs by clicking on the mapping icon in Search for Leads.
You can splice or dice data on biosimilars many ways, for example by factoring in therapeutic area or development phase. A quick search for current biosimilars filed with regulatory organizations and in development allowed me to export, graph and visualize the current state of the biosimilar pipeline over the last five years (Fig. 1).
While many biosimilar drugs are in Phase III trials and soon may be filing for regulatory approval, there are also a large number in Preclinical trials that present earlier opportunities for companies providing clinical drug development services.