Teva Calls on FDA to Make Copaxone a Biologic as Part of March Transition

Regulatory NewsRegulatory News
| 24 February 2020 | By Zachary Brennan 

Beginning 23 March, the US Food and Drug Administration (FDA) is going to convert more than 100 medicines approved under new drug applications (NDAs) to biologics license applications (BLAs) because the Biologics Price Competition and Innovation Act of 2009 and the recent appropriations law broadened the scope of “biological product” to include any protein, including chemically synthesized polypeptides.

Ahead of this switch, FDA published a list of the drugs making this transition, but generic drugmaker Teva Pharmaceuticals is now calling on the agency to add its multiple sclerosis drug Copaxone (glatiramer acetate), which it says is “noticeably absent from this list.”

The move may be part of an effort to restrict competition that already exists as generics for Copaxone, launched as early as 2015.

Teva argues in its comment from last week that Copaxone is a chemically synthesized polypeptide because “glatiramer acetate is a mixture of alpha amino acid polymers having an average length of 40-100 amino acids that is made entirely by chemical synthesis.” FDA has defined a “protein” to mean “any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size.”

And although Teva acknowledges that FDA has previously said that Copaxone is not a protein because “it does not … have a defined and specific sequence,” the company offers two examples of drugs included in FDA’s transition list that are similar to Copaxone.

For instance, the exact chemical structure of Bausch + Lomb’s Vitrase (hyaluronidase for injection) is unknown, according to Teva, which “confirms that the FDA does not require that the exact overall amino acid sequence of a compound be defined or specified in order for that compound to meet the ‘specific, defined sequence’ portion of the ‘protein’ definition.”

AbbVie’s Creon (pancrelipase) is another example Teva uses to show how, like with Copaxone, “the overall sequences of the individual polymers present in Creon are unknown and differ both within each batch and from batch to batch.”

“Glatiramer acetate has an amino acid sequence that is at least as ‘specific’ and ‘defined’ as either of these products, and therefore should similarly meet the ‘specific, defined sequence’ portion of the FDA’s ‘protein’ definition,” Teva argues.

The company also makes the case for Copaxone, even if it is not exactly a biologic, it would still be a “biological product” because “at a minimum, it fits squarely into the catchall category of ‘an analogous product.’”

The comment comes as Teva has previously employed tactics to blunt the effects of incoming generic versions of Copaxone. What remains unclear, however, is if FDA decides to transition Copaxone to a BLA, will the generic versions of Copaxone also transition. In a similar situation, both Sanofi’s Lantus (insulin glargine) and Eli Lilly’s follow-on product Basaglar (insulin glargine) are both on FDA’s transition list.

Copaxone generic drugmakers Mylan and Sandoz did not respond to requests for comment.

Teva Comment


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