Ahead of today's review of Retacrit, Pfizer’s proposed biosimilar of Amgen’s epoetin alfa (Epogen) by the FDA’s Oncologic Drugs Advisory Committee (ODAC), committee members expressed positive views of the drug’s similarity to the reference drug Epogen.
In a review document posted on the FDA website, agency reviewers called Pfizer’s product “highly similar” to Amgen’s Epogen (and Johnson & Johnson’s Procrit, which is the same drug but is marketed for different uses under a licensing arrangement with a California biotech), and wrote that despite minor differences in clinically inactive components, the similarity stood. They further state that there are no clinically meaningful differences between the biosimilar and reference products in terms of the safety, purity, and potency. Pfizer hopes to gain approvals for Retacrit in each of Epogen’s 4 indications:
If approved, Retacrit will be Pfizer’s second biosimilar to be marketed in the United States. Inflectra, Pfizer’s biosimilar of infliximab (Remicade), was approved in November 2016. If approved, Retacrit would also be the second biosimilar approval to compete directly with an Amgen reference biologic product. Amgen is already facing competition from filgrastim-sndz (Zarxio), an approved biosimilar of filgrastim (Neupogen).
Retacrit’s approval, while likely, is not assured. Retacrit has faced prior regulatory denial: in 2015, the FDA issued a complete response letter to Pfizer following Pfizer’s acquisition of Hospira, which had developed the drug. And even if Retacrit is approved, a legal battle with Amgen looms over the marketing of Retacrit. Amgen is suing in federal court to block the launch of Retacrit, alleging that Hospira provided Amgen with notice of commercial launch too soon in the “patent dance” process laid out in the Biologics Price Competition and Innovation Act.
Epogen and Procrit are blockbuster drugs, with each earning over $1 billion in worldwide sales in 2016. Another Epogen biosimilar is likely to add to the competition with Amgen: Sandoz is also preparing to submit an application to the FDA for its Epogen biosimilar.
*Update: Pfizer announced in a press release that ODAC recommended approval of the company's epoetinalpha biosimilar across all the indications listed above. the recommendation will come into play when the FDA evaluates Pfizer's Biologics Licence Application for the proposed epoetin alfa biosimilar.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032
April 11th 2024The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.