- Pfizer is asking the Food and Drug Administration to clarify what makers of branded biologic drugs can say about cheaper, copycat versions of their products, a move that reflects its frustration over the sluggish adoption of biosimilars in the U.S.
- In a citizen petition posted online Monday, Pfizer criticized several of its pharma peers for using "scare tactics" to undermine adoption of biosimilar drugs like its Remicade copy Inflectra. While the FDA has ramped up the pace of biosimilar approvals, the market remains underdeveloped due to patent and contracting hurdles.
- "We believe that a major factor contributing to this slow uptake is a lack of market confidence in biosimilars resulting from the efforts of certain reference product sponsors to disseminate false and misleading information that casts doubt about the safety and efficacy of biosimilars in the minds of patients and prescribers," Pfizer wrote in its petition.
Biosimilars have driven a rare wedge between large pharma companies, as major drugmakers like Pfizer take aim at the top-selling blockbusters of their peers.
The copycat biologics threaten to steal market share away from drugs that have so far enjoyed dominant market positions, like Johnson & Johnson's Remicade (infliximab), Roche's Herceptin (trastuzumab) or Amgen's Enbrel (etanercept). Being cheaper, biosimilars could also bring real savings to a healthcare system struggling to cope with rising drug costs.
But it hasn't worked out in the U.S. quite as some, like Pfizer, had hoped. Patent litigation has blocked market entry of many approved biosimilars, while defensive contracting has slowed sales for those biosimilars that have reached patients. While the FDA has OK'd 11 biosimilars, only three are currently available.
In its petition, Pfizer partially blames fellow drugmakers that hope to blunt the impact of biosimilar challengers. Specifically, the pharma accuses companies like Amgen, Roche's Genentech unit and J&J's Janssen of disseminating misleading information that inaccurately raises questions about the safety and efficacy of biosimilars.
Amgen, for example, suggested in a tweet that differences between biologics and biosimilars could cause some patients to react differently. That, according to Pfizer, undermines the idea that an approved biosimilar is proven to have no clinically meaningful differences with its reference biologic.
Biologics or biosimilars? It’s not just apples to apples. While #biosimilars may be highly similar to their #biologic reference products, there’s still a chance that patients may react differently. See what you’re missing without the suffix: https://t.co/k5i6R5YPcI pic.twitter.com/l8EaLmxSkC— Amgen Biosimilars (@AmgenBiosim) April 13, 2018
However, Amgen contends its "Circle The Suffix" educational campaign is designed to educate physicians on appropriate use of the suffix that appends the non-proprietary name of biologics and biosimilars (the "-atto" at the end of the scientific name for Amgen's biosimilar Amjevita, adalimumab-atto, for instance).
"As a manufacturer of both novel biologics and biosimilar medicines, Amgen is fully committed to the success of the biosimilars market and to our biosimilars portfolio of 10 biosimilars which target some of the most complex and important biologics medicines," Amgen said in a statement emailed to BioPharma Dive.
To date, Pfizer has won the FDA's OK for four biosimilars in the U.S. and hopes to bring five biosimilars to market within the next two years. Sales of its earliest approved biosimilar Inflectra (infliximab-dyyb), however, have been modest in the U.S. — a state of affairs that Pfizer believes is due to exclusionary contracting by J&J with U.S. insurers for branded Remicade.
While Pfizer acknowledges that issues of coverage by insurers is outside the scope of FDA authority, it argues the regulator can issue clearer biosimilar guidance and shape payer behavior.
To that end, the pharma's citizen petition asks the FDA to clarify what kind of communication from reference biologic makers would be misleading, and to lay out a clearer path for how biosimilar manufacturers can promote their products.
For its part, the FDA is working to lower barriers to biosimilar adoption, last month issuing an action plan meant to foster a more competitive market.