Momenta Pharmaceuticals, Inc. (MNTA)

[floblu14]

What the hell does that mean?

If the FDA regulations for interchangeable biosimilars are set too low, there is no money to be made for MNTA (vis a vis competition) even with their technical expertise.

As stated earlier:

April 14, 2016
FDA Stays Mum on Interchangeable Biosimilar Guidance

The FDA will release a draft guidance on biosimilar interchangeability this year, the agency's biotechnology director told an April 12 conference, but he didn't address how interchangeables would be named.

The agency has released three final guidances to industry concerning these lower cost versions of biologics and will finalize five draft guidances by year's end, said Steven Kozlowski, director of the Food and Drug Administration's Center for Drug Evaluation and Research's Office of Biotechnology Products.

The agency also plans to release two additional draft guidances before the end of 2016, he said, including one on interchangeability—determining whether a pharmacist can substitute a biosimilar for the original biologic without a physician's approval. But Kozlowski didn't provide any details about the highly anticipated interchangeability draft guidance.

“I think our primary consideration there will be on the scientific basis and expectations for interchangeability, but I really can’t comment on what's going to be in it until the draft guidance is out,” he said.

http://www.bna.com/fda-stays-mum-n57982069888/