The rubber has hit the road in the debate over legislation, approved in March, to create a regulatory pathway for generic versions of cell-based drugs known as biosimilars. The U.S. Food and Drug Administration has yet to issue rules on the new law, which would give the “innovator companies” — those who produce the name-brand biologics — 12 years of data exclusivity before their drug patents can face competition.
But the biotechnology world got a peek into the future landscape of generic biologic competition this summer, when Momenta Pharmaceuticals Inc. in Cambridge gained approval for its generic version of the anticoagulant Lovenox, made by French pharmaceutical company Sanofi-aventis.
Momenta did not gain approval based on the new law but through an alternative regulatory pathway, in place for years. The example, however, puts a sharp point on what’s at stake — both in terms of intellectual property and millions of dollars. Momenta announced last month that it had its first profitable quarter. Its biosimilar, called M-Enox, brought in revenue of $292 million in its first 69 days on the market, which Momenta shared with its partner, Sandoz Inc., the generics arm of pharma Novartis AG. In less than one quarter, the generic biologic chomped into Sanofi’s market share, cutting the French firm’s revenue in half and putting the Momenta drug on the path to becoming a blockbuster.