In its role as the government entity that is in charge of promoting biosimilar uptake in the United States, the FDA is continually striving to balance innovation and competition, an FDA official told an audience at ISPOR 2019 annual meeting.
The Wednesday session, called “How Can Biosimilars Make Headway in the USA? Dealing With the Legal, Regulatory, Payer Coverage Policy, And Access Challenges,” featured biosimilar experts who reviewed the current state of affairs and various challenges related to uptake, while also sounding some notes of optimism.
Just yesterday, the FDA released its draft guidance
on the design and evaluation of comparative analytical studies that are intended to support a demonstration of biosimilarity, noted Eva Temkin, JD, acting director of policy, Office of Therapeutic Biologics and Biosimilars, at the FDA’s Center for Drug Evaluation and Research.
She also reviewed the recently released final guidance
, “Considerations in Demonstrating Interchangeability With a Reference Product,” which provides FDA’s current thinking
on scientific considerations in demonstrating that a proposed biological product is interchangeable with a reference product. The term “interchangeable” or “interchangeability” means that a biosimilar may be substituted for the reference product without the intervention of the prescribing clinician at the pharmacy level.
Temkin stressed that there is no “one-size fits all” assessment, and that the FDA uses a “totality-of-the-evidence” approach, and sought to retain flexibility so that the FDA could give specific advice to prospective applicants.
In addition, she highlighted one aspect from the draft guidance that did not fully make it into the final version. The draft guidance “strongly recommend[ed]” the use of a US-licensed reference product in switching studies.
“The final guidance pulled back on that a bit,” she said. The final guidance left out the “strongly recommends” statement and includes considerations for the type and extent of “bridging” data needed to justify the use of a non-US licensed comparator in switching studies
As of May 1, the FDA has approved 19 biosimilar license applications for 9 reference products; the FDA believes that 8 biosimilar products have been commercially launched. Temkin said 78 programs (for 36 different reference products) were enrolled in the Biosimilar Product Development (BPD) Program to discuss development of proposed biosimilar products or interchangeable products.
She said 16 companies have publicly announced that they plan to file 29 submissions under the abbreviated pathway allowed for biosimilars and biologics under the Public Health Services Act.
Coming up, she said the FDA is planning an enhanced version of its Purple Book
, which is to biologics and biosimilars what the Orange Book
is to generic, branded prescription, and over-the-counter drugs.
Ha Kung Wong, JD, MBA, a patent attorney with Venable Fitzpatrick, also noted that the Purple Book is the subject of pending Congressional action. The House of Representatives unanimously cleared “The Purple Book Continuity Act of 2019” earlier this month. If passed, it would require the FDA to add more detailed information on biological products and make the data available in a searchable, electronic format. The Senate has also passed a similar bill, the Biologic Patent Transparency Act.
Both bills are aimed at untangling the so-called patent thickets that critics say stymie pharmaceutical competition and keep drug prices high.
Chad Pettit, the executive director of Global Value Access and Policy for Amgen’s Biosimilars Business Unit, gave an upbeat perspective, saying, “the biosimilars marketplace is really, really lifting off.” There have been 4 products launched in past year in the United States and 7 since 2015.
He also mentioned the cost savings that biosimilars are expected to provide, citing an IQVIA report that said biosimilars saved $7 billion this year and predicts that further use will generate $60 billion in savings by 2023.
Moderator Anita Burrell, an executive with EVERSANA, a life sciences services firm, asked the panel their views about the biggest hurdles in the US market.
Pettit said that while many comparisons are often made with the European marketplace, where biosimilars had an earlier start, have a different reimbursement system, and have not had the patent challenges that exist here, he cautioned any takeaways be general in nature. “You need to have a balance so that there is sustainability in the marketplace,” he said.
However, more education, aimed at different stakeholders, is still needed here, panelists said. The FDA is using the experience of what it saw previously with generic drugs entering the marketplace years ago to help guide some of the discussions now, Temkin said.
“It is difficult to talk about biologics and biosimilars in a way that people understand,” she said.