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Biosimilar Regulatory Roundup: February 2020


The FDA announced changes or updates to several policies. Chief among them: final guidance on a regulatory shift for insulin and certain other products.

February was a busy month for the FDA as they announced changes to several policies, while preparing for the shift in how insulin and certain other products transition to a biologics pathway in late March.

The month kicked off with the FDA and the Federal Trade Commission (FTC) publishing draft guidance for the industry about how to advertise and promote biologic products without making false or misleading statements. This was done in an effort to encourage collaboration to support a more competitive market for biosimilars and interchangeable products.

The FDA also announced it will review patent settlement agreements involving biosimilars to prevent antitrust violations. These issues and more will be discussed at an FDA public workshop on March 9.

In addition, the FDA published draft guidance that shortens a review period for certain supplements by 4 months. The agency will now review and act on original 351(k) biologics license applications (BLA) supplements with clinical data within a 6-month time frame, as opposed to a 10-month waiting period. This is intended to expedite the review process for biosimilar supplements and can be used to update initial biosimilar approvals when it is for fewer than all the approved conditions for the reference product.

According to the guidance, biosimilars or interchangeable products cannot be licensed for an indication by the FDA if they are protected by orphan drug or pediatric exclusivities, until those exclusivities expire.

Also in February, the FDA released final guidance about the regulatory transition happening in March, affecting what are currently called follow-on insulins and other products.

As required by the Biologics Price Competition and Innovation Act (BPCIA) of 2009, the new “Deemed to be a License” provision is being added to the BPCIA on March 23, 2020. This rule change will alter the current definition of biological product.

Some protein products (eg, insulin and insulin analogs, human growth hormone, pancreatic enzymes, and reproductive hormones) had been approved under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Under the change, drug developers will file these as BLAs under the Public Health Service (PHS) Act instead.

In preparation for the policy change, the FDA published its final rule about the shift by amending the definition of “biological product” to remove the parenthetical “(except any chemically synthesized polypeptide)” from the category of protein. The parenthetical was originally included in the BPCIA in section 351(i) of the Public Health Service (PHS) Act.

The FDA hopes the changes will reduce “regulatory uncertainty’ and allow both the FDA and private industry to avoid spending time and resources on case-by-case determinations for each product.

Later in the month, the FDA launched the first phase of its improvement to the Purple Book by shifting from a list format to a searchable database for the public to easily search biosimilar and biologic products. Although the old list is still available as updates continue, the FDA says they will also publish a Federal Register notice and open a docket to gather public comment on the database to inform the next phases of development.

The Purple Book’s goal is to enhance functionality and include all Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research regulated products, including transition biological products. Once all the updates are complete, the original list will cease being updated.

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