Biotechs go generic: The same but different

Heidi Ledford¹

As several lucrative protein-based drugs are poised to go off patent, makers of biopharmaceuticals argue that their products are too complex to be reproduced as generics. Heidi Ledford investigates how close 'biosimilar' drugs can get to the original.

In 2006, Craig Wheeler, then president of Chiron BioPharmaceuticals in Emeryville, California, received a call from across the country that would challenge his perspective on the biotechnology industry. Momenta Pharmaceuticals, a small firm in Cambridge, Massachusetts, was looking for a new chief executive. The company planned to develop new drugs, in part relying on its ability to detect and manipulate the carbohydrate molecules that decorate proteins. But Momenta also intended to create generic versions of therapeutic proteins, something that Wheeler says he thought was impossible.

Unlike the straightforward industrial chemistry techniques used to make small-molecule drugs, the methods of producing and isolating 'biologics' — complex drugs, vaccines or antitoxins made by or from living cells — can be complex and fickle. "The process is the product" was the mantra of the biopharmaceutical world, says Wheeler. Even those who developed drugs in the first place were loath to play around with their methods. "We were deathly afraid of changing anything because we couldn't tell where it would lead," he says.

Debate has flared over whether proteins are too complex to be copied. Even nomenclature for the replicants has changed as a result. Many have discarded the term 'biogenerics' in favour of 'biosimilars', saying that the word 'generic' unfairly implies a perfect replication. And companies and lobbyists on both sides are battling over whether biosimilars should be allowed to follow the fast track to approval available for small-molecule generics, or whether they should undergo expensive clinical trials beforehand. Pending US legislation on the matter could result in billions of dollars being won or lost by companies such as Momenta and the larger biotechnology and pharmaceutical companies that own the ageing patent rights to biologic drugs.

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