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Author Archives: Chip Carnathan

Formal Meetings with FDA for Biosimilar Products

February 10, 2016 | Chip Carnathan, PhD, RAC, Director Regulatory Affairs | Regulatory Affairs, Drug Development Consulting

Yeah, yeah, we know. The general public considers biosimilars to be “generic” versions of approved biological products. The FDA has gone to great lengths to disavow us of this perception because, as we have discussed before, there cannot be a true generic version of a biologic product.

The FDA recently finalized a procedural guidance entitled “Formal Meetings between the FDA and Biosimilar Biological Product Sponsors or Applicants.” Since these meetings are intended to discuss the development of biosimilar products, it is somewhat appropriate that FDA chose to be “non-generic” in its design of these meetings!

Differences between BsUFA and PDUFA Formal Meetings

Formal meetings between Sponsors and the FDA on biosimilar development programs were authorized by the Biosimilar User Fee Act of 2012 (BsUFA), which was included in that year’s Food and Drug Administration Safety and Innovation Act (FDASIA). While the BsUFA meeting program is similar to the Pharmaceutical Drug User Fee Act (PDUFA) meeting program, there are some meaningful differences.

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The Role and Responsibilities of a Sponsor’s Authorized Representative

November 19, 2015 | Chip Carnathan, PhD, RAC, Director Regulatory Affairs | Regulatory Affairs, Drug Development Consulting

A person does not have to work in the field of US Regulatory Affairs for any meaningful length of time before needing to complete a Form 1571. Virtually all regulatory submissions pertaining to INDs include this document, which can be viewed as a tabular cover letter describing the contents of the submission.

Line 17 of the form identifies a person as the “Sponsor or Sponsor’s Authorized Representative” and, ultimately, that person signs the form.

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Don’t Be Afraid! 5 Keys to Successfully Opening an IND

October 30, 2015 | Chip Carnathan, PhD, RAC, Director Regulatory Affairs | Regulatory Affairs, Drug Development Consulting

As Halloween approaches, many of us go into a role-playing mode and think of the alter-ego we will assume. Superheroes and vampires are common choices and preparing to spend the night in one of these roles can be fun. In reality, not too many of us actually become a superhero or a vampire, so our role-playing stops at the stroke of midnight when the calendar flips into November.

Imagine, however, that this year you decided to become a biotechnology entrepreneur. This choice is not a one‑night fantasy but is a conscious decision to start or join a new, start-up biotechnology company. What will you do when the calendar flips to November? How do you prevent that choice from becoming a horror story?

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Current Status of Biosimilars in the United States

May 14, 2015 | Chip Carnathan, PhD, RAC, Director Regulatory Affairs | Regulatory Affairs, Drug Development Consulting

Two watermark events have occurred this year concerning the development of biosimilar products in the US:

As all good drug development professionals know, we must look at the relevant FDA guidance documents when designing an effective drug development plan. The publication of these 3 Biologics Guidance Documents removes any ambiguity which can arise from the use of draft documents.

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