Biosimilar Developers Seek Clarity on US FDA Draft Guidance

By Zachary Brennan

- Last updated on GMT

Biosimilar Developers Seek Clarity on US FDA Draft Guidance

Related tags Food and drug administration Fda

Biosimilar developers such as Mylan and Pfizer are taking issue with FDA draft guidance that in some circumstances could extend biosimilar development timelines and discourage their development.

Under the Biosimilar User Fee Act of 2012, biosimilar sponsors or applicants can request meetings at different stages of the development process. But unlike submissions of NDAs (New Drug Applications) or BLAs (Biologic License Applications), where sponsors have to pay fees when the applications are submitted, biosimilar developers must pay fees during development stages.

Eight different biosimilar developers submitted comments​ on the FDA draft guidance for industry on formal meetings between the FDA and biosimilar sponsors and applicants, and most of the commenters seek clarity on the types of data that should be submitted along the way.


Mylan seemed to offer one of the most damning views of the guidance, despite saying it appreciates the release of the draft. Andrea Miller, SVP of biologics for Mylan, writes, “The increased timelines for an Agency response and rigorous deadline for meeting materials will lead to delays in biosimilar development and may possibly lead to a chilling effect on biosimilar development​.”

At current biosimilar user fee levels, Mylan says it finds the meeting metrics proposed in the draft guidance “both inequitable and unjustified​.”

Biosimilars follow an abbreviated development pathway, and at most, should require no more Agency resources than the review of a novel drug subject to PDUFA [Prescription Drug User Fee Act] timelines​,” she continues.

Boerhinger Ingelheim seems to echo those sentiments, noting that the procedures for scheduling such meetings should not be too different from those for scheduling other types of meetings with the FDA. But the current timelines as proposed “are too protracted and complicate the Agency’s advice to sponsors to have a step-wise approach to biosimilar development​.”

One of the proposed timelines for when the FDA must schedule a meeting “could lead to a four month or longer inactive period where development is likely stalled​,” Mylan said.

More Clarity

Pfizer, however, seeks clarity on when the FDA would notify sponsors when the type of meeting would be altered from one in which a fee would not be necessary to one in which it would be necessary.

The initial advisory meeting is when a sponsor or applicant would meet with the FDA to discuss the feasibility of developing a product as a biosimilar, and would not require a fee, but a so-called Type 3 meeting occurs during the development of a biosimilar and does require a fee.

Pfizer also seeks clarity on when such a product development meeting might be withdrawn as a result of the FDA’s changing the type of meeting. In addition, cases for what the FDA might deem “unusual circumstances​” when requests for meetings might not be honoured by the agency need more details as well, Pfizer said.

Teva, meanwhile, would like more clarity on what briefing documents will meet the FDA’s expectations in terms of scheduling an initial advisory meeting rather than a biosimilar product development meeting that would require a fee. 

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