A Blueprint for Biosimilars?

As expected, biosimilars news made top headlines right out of the starting gate in 2015, with Novartis’s biosimilars version of filgrastim gaining a 14-0 positive vote by the FDA’s independent Oncologic Drugs Advisory Committee on Jan. 7th. The unanimous recommendation for approval within the next few months paves the road forward for the first official U.S. approval of a biosimilars medicine. Here are the fast facts around the application, approval process, and biosimilars market as a whole, according to FierceBiotech:

  • 14-0 vote was to approval biosimilars filgrastim (which boosts white cell production) for all five indications approved for originator Amgen’s Neupogen
  • Novartis’s generic arm, Sandoz, already has Zarzio (biosimilar Neupogen) approved in 40 countries, and is poised to lead the rush of U.S. biosimilars
  • Sandoz claims to hold more than 50% share of the world biosimilars market, with a late stage biosimilar pipeline including copies of Humira, Enbrel, Rituxan, and Procrit
  • Novartis was the first to file for a U.S. biosimilars under the FDA’s “newly created pathway” when it submitted biosimilar filgrastim over the summer

The New York Times reported the week of Jan. 5th that Express Scripts said the U.S. healthcare system could save roughly $250 billion over the next 10 years thanks to the rise of biosimilars. The global biosimilar market boom serves as a sneak preview of what’s to come in the U.S. A report from Allied Marketing Research put worldwide sales of copycat biologicals at $35 billion by 2020, with huge patent cliffs and regulatory changes driving the growth.

It is interesting to note that on the same day of Novartis’s positive opinion from the FDA Advisory Committee, the Biotechnology Industry Organization (BIO) urged the FDA to officially and publicly release guidance on its processes and scientific criteria for the approval of biosimilars.

Then, one week later, on Jan. 12th, Hospira, a global leader in biosimilars, announced that it had submitted a Biologics License Application (BLA) to the U.S. FDA for Retacrit, a proposed biosimilar to Amgen’s Epogen (epoetin alfa) and Janssen’s Procrit (also an epoetin alfa). The biosimilar application was submitted on Dec. 16, 2014, under the new 351(k) approval pathway created by the Biologics Price Competition and Innovation Act of 2009 (BPCIA).

Fletcher/CSI believes the three events are not only related, but also foretelling of events on the U.S. biosimilars horizon. We expect to see an uptick in news around BLAs, the FDA’s willingness to adopt biosimilars, and overall activity in the space. In some regards, the biosimilars incursion of Neupogen, Epogen, and Procrit should be considered the tip of the iceberg.

In 2015, the race between biosimilars Lantus developers Eli Lilly and Boehringer Ingelheim against Merck and Samsung is expected to heat up. Also a rush is expected as Humira (AbbVie loses patent exclusivity in the end of 2016), Enbrel (Amgen), Remicade (J&J/Merck), Herceptin (Roche), and others face significant patent cliffs over the next two to three years. Other players leading the hunt for biosimilar glory include Hospira (with Celltrion for biosimilar Remicade) and Mylan (with Biocon for biosimilar Herceptin).

Fletcher/CSI Life Sciences’ primary research, advisory, strategic planning, monitoring, and conference coverage services are available to support and take advantage of biosimilar market opportunities today. Please give us a call, email, or visit our website for more information.