FDA Receives Conflicting Sets Of Analyses/Comments — On Biosimilar “Interchangeability” Label Copy Proposals — From Industry

In the EU (as may be seen at right — black and white imagery), the EMA and the ECC are out well ahead of the US on handling labeling, from a regulatory perspective — when a so-called “biosimilar,” for a “reference product” becomes available for sale. Admittedly, the approach varies by geography. I have included the handy NCSL state by state legislation map, as well — to show that at the state level, we have similar differences. In the end, FDA here in the US will make a final binding pronouncement. In truth though, many are frustrated by the time the FDA is taking to get to its decision point.

Now, with PhRMA, Pfizer, Amgen and Abbvie taking one approach in their comment letters — and Merck (comment letter here, as a PDF file), along with Boehringer Ingelheim (and Sandoz) — suggesting that more definition-setting groundwork is needed, rather than a “blanket” label copy approach — I would guess the US will remain stuck in limbo, for at least a little while longer. So — this post is to encourage other stakeholders to get comments in to FDA — and suggest that whatever is done — it is high time to move the ball forward. Here’s a few bits from the Pfizer — and Merck — letters, courtesy of the RAPS newsletter, overnight. Do go read the source in its entirety, as I am dropping in only a very small portion:

. . . .Pfizer said in its comments that biosimilars should not be labeled “as though they were small molecule generic drugs” and that it “recommends that biosimilar labeling include a statement reflecting whether interchangeability has been assessed.” Pfizer also said it “has substantive concerns about the Agency’s approach to biosimilar data in biosimilar labeling as well as the Agency’s characterization of such data as a general matter.”

“The draft guidance suggests that biosimilar data ‘are not likely to be relevant’ or ‘useful’ to health care practitioners and ‘may cause confusion, resulting in an inaccurate understanding of the risk-benefit profile of the product.’ This language and the related discussion should be struck from final guidance,” Lisa Skeens, VP of global regulatory affairs, writes. . . .

[On the other hand, Merck] says “that a single blanket approach applicable to all biosimilar products (e.g., inclusion of a statement on all biosimilar labels that a biosimilar [is] [is not] interchangeable with its reference) is not appropriate, and may cause unnecessary confusion among stakeholders.”
Merck recommends that rather than using such blanket statements, FDA take a risk-based approach for each biosimilar “when determining if a recommendation is necessary ‘to inform safe and effective use by a health care practitioner.’

“As a fundamental point, any policy approach to interchangeability labeling is premature without first defining the regulatory standards of an ‘interchangeable biologic,’” Andrew Robertson, director of global regulatory policy at Merck, writes. . . .

Similarly, Boehringer Ingelheim says that it “does not agree that a biosimilar label needs to include a ‘biosimilarity statement,’ i.e., a statement that the product is a biosimilar. Such information is not ‘essential scientific information needed by health care practitioners for the safe and effective use of a drug.’ It is nonetheless available in the Purple Book, and not in any manner hidden.”. . .

It was once thought that the central purpose of forming, funding, and maintaining trade groups like PhRMA was to help coordinate the industry’s preferred approach to regulatory initiatives.

I do well-understand that some PhRMA members like Merck (i.e., ones in various ventures to bring biosimilars to market) have slightly differing goals, than some of the old-line, pure reference manufacturers (and thus this all looks more than a little like the old school generic v. branded days), this has all become. . . more complicated. Pfizer itself is seeking at least one biosim approval, while Amgen is resisting one. In fact, most of the letter writers have at least one product candidate (directly, or a joint venture in the works), that will bring a biosim to market. SO — everyone is conflicted here. As I say, if you have expertise to share here, please do take the time to write.

Onward, on a glorious steamy summer morning — grinning ear to ear, at the mess the “we shall overcomb” candidate has made of his own life, and flailing fortunes. . . .

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