UPDATE: Just two days after an FDA subcommittee recommended the approval of Novartis/Sandoz's biosimilar of Amgen's Neupogen, which will be marketed as Zarxio in the United States (and is already approved and marketed as Zarzio in than 40 other countries), a panel of U.S. advisers made a similar recommendation during a meeting on Wednesday. Although the advisers' recommendation isn't binding, it brings the Novartis biosimilar's approval yet another step closer to expected FDA approval, which will make it the first-ever approved biosimilar in the United States under the new 351(k) regulatory pathway.
Johns Hopkins oncology chair and FDA panel chairwoman Deborah Armstrong noted biosimilar filgrastim's worlwide record in a statement to Bloomberg. “This has been utilized extensively in other parts of the world,” said Armstrong. “There’s fairly robust safety and efficacy data that makes some of this a little bit easier.”
- The FDA has been advised by one of its subcommittees to approve Novartis's biosimilar version of Amgen's Neupogen, which is already marketed as Zarzio by Novartis' generics arm Sandoz in many other countries (Note: Updated above). The biosimilar filgrastim is the first drug to be recommended under the FDA's new 351(k) pathway for generic versions of biologics.
- Neupogen is used to bolster immune function in patients with breast cancer who are undergoing chemotherapy.
- Zarzio is already approved as a biosimilar in more than 40 countries outside of the U.S.
The likely impending approval of this biosimilar in the U.S. will represent an important milestone and could help other companies seeking biosimilar approvals in the U.S. as they prepare to file their applications.
Biosimlars cost roughly 20% to 30% less than their biologic equivalents and represent an important option for both payers and patients. In fact, by 2020, off-patent biosimilars are expected to generate $25 billion in revenues.