Regulatory Open Forum

On the Regulatory Focus edition from June 21th, 2021 we learned that the FDA has issued a final guidance regarding notification of Chemistry, Manufacturing, and Control (CMC) post-approval manufacturing changes for biological products. Among the products in scope for this guideline are vaccines, allergenic products, plasma-derived products, antisera, etc. Interestingly, products not in the scope are therapeutic DNA-derived and synthetic peptide products, and mAbs, including biosimilars.

The exclusion of mAbs, including biosimilars, came to my attention, and is one of the comments that PhRMA had for this document. Why are mAbs excluded from this guideline, in opinion of RAPS members?

FDA issues final guidance on CMC postapproval changes for biologics

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Luis Peña-Ortiz
Jena
Germany
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This message was posted by a user wishing to remain anonymous

Simply put class of biologics (therapeutic mabs etc) different from Vaccines, plasma derived products etc.....
Original Message:
Sent: 22-Jun-2021 11:59
From: Luis Peña-Ortiz
Subject: FDA CMC post-approval changes / mABs out of scope?

On the Regulatory Focus edition from June 21th, 2021 we learned that the FDA has issued a final guidance regarding notification of Chemistry, Manufacturing, and Control (CMC) post-approval manufacturing changes for biological products. Among the products in scope for this guideline are vaccines, allergenic products, plasma-derived products, antisera, etc. Interestingly, products not in the scope are therapeutic DNA-derived and synthetic peptide products, and mAbs, including biosimilars.

The exclusion of mAbs, including biosimilars, came to my attention, and is one of the comments that PhRMA had for this document. Why are mAbs excluded from this guideline, in opinion of RAPS members?

FDA issues final guidance on CMC postapproval changes for biologics

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Luis Peña-Ortiz
Jena
Germany
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Luis, the new final guidance you referenced primarily concerns CBER-regulated biologics. Monoclonal antibodies (mAbs) and other therapeutic proteins are regulated by CDER, per an announcement from 2003. Although CDER is a signatory on this guidance, it has its own set of guidance documents covering post-approval changes (some of which are quite dated and are available via the FDA guidance search). Note that similar approaches may apply regardless of product type, and overarching guidance such as ICH Q12 and its accompanying FDA implementation considerations will also likely be applicable.

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Jonathan Amaya-Hodges
Associate Director, Regulatory Affairs CMC Combination Products and Medical Devices
Cambridge MA
United States
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Original Message:
Sent: 22-Jun-2021 11:59
From: Luis Peña-Ortiz
Subject: FDA CMC post-approval changes / mABs out of scope?

On the Regulatory Focus edition from June 21th, 2021 we learned that the FDA has issued a final guidance regarding notification of Chemistry, Manufacturing, and Control (CMC) post-approval manufacturing changes for biological products. Among the products in scope for this guideline are vaccines, allergenic products, plasma-derived products, antisera, etc. Interestingly, products not in the scope are therapeutic DNA-derived and synthetic peptide products, and mAbs, including biosimilars.

The exclusion of mAbs, including biosimilars, came to my attention, and is one of the comments that PhRMA had for this document. Why are mAbs excluded from this guideline, in opinion of RAPS members?

FDA issues final guidance on CMC postapproval changes for biologics

------------------------------
Luis Peña-Ortiz
Jena
Germany
------------------------------