In a move that underscores the changing landscape of the pharmaceutical industry, the chief trade group has officially accepted one of the world’s largest generic drug makers into its ranks.
Last Friday, Teva Pharmaceuticals became a member of the Pharmaceutical Research and Manufacturers of America, which has burnished its reputation on Capitol Hill and elsewhere as a staunch defender of brand-name companies.
The decision to accept Teva, which had been telegraphed in recent days, came as a surprise to some industry watchers, given the historical rivalry between brand-name and generic manufacturers.
For decades, generic companies have thrived by offering lower-cost versions of more expensive brand-name medicines, but they typically must endure long-running and costly litigation over patents before winning the right to sell their copycat drugs.
The move, however, isn’t all that unexpected, if only because the lines are beginning to blur.
This is particularly noticeable when eyeing the burgeoning market for biosimilars, which are nearly identical versions of pricier, brand-name biologic medicines. Already, two of the world’s largest brand-name drug makers are players, although US regulators have, so far, approved only two such drugs.
Novartis, for instance, owns Sandoz. Meanwhile, through its acquisition of Hospira, Pfizer also sells these medicines, although Pfizer was already developing its own unit, before striking that deal. And Amgen, one of the largest biotechs, has also been developing biosimilars.
And while Teva is one of the largest generic manufacturers, the company has also marketed brand-name medicines, such as the Copaxone multiple sclerosis treatment.
Moreover, the strategic interests of brand-name and generic companies are increasingly overlapping. Although generics are generally priced much lower, some congressional lawmakers have focused on rising prices for copycat drugs, suggesting all of these companies increasingly share lobbying concerns.
And last year, the brand-name and generic industry trade groups teamed to fend off a proposal by the US Food and Drug Administration to require generic companies to upgrade their product labeling as safety information becomes known. The trade groups have succeeded in delaying the proposal.
Such developments undermine the argument that being a company can’t be a low-cost provider and simultaneously become a member of the brand-name club.