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Richmond Va-based INSMED, a US-based follow-on biologics manufacturer, posted a press release on its website entitled: “Insmed Announces First Human Bioequivalence Data for a Follow-on Biologic by a U.S. Company” that reports on the results from a Phase I clinical trial that demonstrated that it lead product INS-19 was bioequivalent to Amgen’s Neupogen^(R) (recombinant G-CSF) in stimulating human white blood cell production. 

, Dr. Geoffrey Allan, President and CEO of Insmed said  "These results are very exciting, as they represent Insmed's ability to replicate a protein product, to bring that product rapidly through the clinic and to demonstrate clear bioequivalence to the innovator drug," said "To our knowledge, we are the first U.S. company to report human bioequivalence data for a follow-on biologic product, validating the idea that follow-on biologics can be a scientific reality in the U.S. and that Insmed is well positioned to be a leader in the field. “ The company has requested a meeting with FDA to discuss the design of a Phase III human clinical trial for INS-19.

I am not sure why INSMED is so excited about its results. Sandoz essentially accomplished the same feat with Omnitrope, its biosimilar version of recombinant human growth hormone (HGH)and it took a law suit and a loophole in the approval process for growth hormones for FDA to allow it to be sold in the US. In my opinion, until legislation is passed that provides a clearly defined legal pathway for approval of follow-on biologics I suspect that INS-19 will suffer the same fate (or perhaps worse) than Omnitrope. Bioequivalence is only legal defined for and relevant for approval of small molecule NOT BIOLOGICS when seeking expedited approval for generic versions of branded products. That said, I want to tip my hat to INSMED for its willingness to take a lead role in the fight to get follow-on biologics approved in the US. Finally, there is nothing like an edgy press release and a few bloggers to bring an issue that is rapidly losing momentum back to the forefront.

Kudos to INSMED!!!!!!

Until next time….

Good Luck and Good Job Hunting!!!!!!

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The Massachusetts-based biotechnology company, Momenta Pharmaceuticals, announced late yesterday that FDA refused to approve its ANDA filing for M-Enoxaparin, a generic version of Sanofi-Aventis' Lovenox®. The agency cited that Momenta had failed to provide data in its application on the potential immunogenicity of M-Enoxaparin. I find this oversight to be extremely perplexing because Momenta’s management team had to know that regulatory approval of a product –considered to be a follow-on biologic (M-Enoxaparin is a synthetic version of low molecular weight heparin which is a polysaccharide) – would require a rigorous assessment of the product's  potential immunogenicity. If Momenta did not know about the immunogenicity requirements, then Sandoz (its co-development partner) had to be keenly aware of them because Sandoz had to provide immunogenicity data to FDA to garner approval last year of Omnitrope®, a follow-on version of human recombinant growth hormone (rHGH).

Although FDA’s refusal to approve M-Enoxaprin is a setback for the follow-on biologics movement in the US, it is about time, in my opinion, that Momenta’s stock price truly reflects the real market value of the company. Much to my surprise, Momenta’s stock price was over $30 a share about two years ago– presumably founded in the notion that the company’s innovative carbohydrate technology platform could be used to create a generic version of Sanofi’s multi billion dollar a year Lovenox® . I have no doubt that Momenta’s technology platform is one of the more innovative ones in the carbohydrate synthesis biz. However, as a former employee of 2 biotech companies founded on revolutionary carbohydrate synthesis platforms, I think that Momenta’s elevated stock price had more to do with the pedigree of scientists who started the company and the ROI that these scientists previously provided to the VCs who are currently backing Momenta. Further, cutting a deal with Sandoz, a company whose name is now synonymous with follow-on biologics may also have contributed to the elevated stock price.

If I was one of Momenta 100 or so employees I would be dusting off that resume right about now.

Unitl next time....

Good Luck and Good Job Hunting!!!!!!

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