Anticipating regulations, biosimilars move through pipeline

Though efforts to repeal the Patient Protection and Affordable Care Act via the court system remain under way — with recent victories for opponents in Virginia and Florida — the attempt to repeal the healthcare-reform bill in Congress failed, thus leaving the bill and, most importantly, the regulatory approval pathway for follow-on biologics intact.


Whatever the outcome, progress on follow-on biologics — also called biosimilars or biogenerics — has hummed along over the past several months. Sandoz, the generics arm of Swiss drug maker Novartis and a key biosimilars manufacturer for the European market, has as many as 10 biosimilar compounds under development, according to reports published in early February.


Meanwhile, Momenta Pharmaceuticals announced that it received a patent from the U.S. Patent and Trademark Office that included a way of preparing glatiramer acetate. Momenta is hoping to market a generic version of the drug, which Teva Pharmaceutical Industries, together with Sandoz, markets as a multiple sclerosis treatment under the brand name Copaxone. Though the Food and Drug Administration approved Copaxone as a pharmaceutical drug, its chemical complexity places it in league with biotech drugs, similar to Sanofi-Aventis’ blood thinner Lovenox (enoxaparin sodium), for which Teva recently began marketing a generic version.


In the meantime, Teva — which also makes biosimilars for the European market — has sought to use the existing approval process for biologics to win approval for follow-on biologics in the United States, meaning that it still must subject the drugs to clinical trials. In addition to its generic version of Lovenox, Teva sought approval from the FDA for a biosimilar of Amgen’s Neupogen (filgrastim), which it already markets in Europe and hoped to launch in the United States under the name Neutroval, though the FDA declined to approve it. 


In January, Spectrum Pharmaceuticals and Viropro announced plans to develop a biosimilar of Rituxan (rituximab), a Genentech drug used to treat cancer.


Formal regulations still could be years away, even if guidance for draft regulations appear this year, industry experts have told Drug Store News. In November 2010, the FDA brought together representatives of the generic drug, branded drug and biotechnology lobbies to offer input about what form regulations for follow-on biologics should take.


When those regulations finally do appear, they’ll be somewhat more complex than the ones for generic pharmaceutical drugs. For one, biosimilar manufacturers still will have to conduct clinical trials. Unlike pharmaceuticals, the molecular complexity of biologics and the fact that they come from specially grown cell lines make it more difficult to create exact replicas of the originals, so the trials would have to demonstrate that the follow-on biologics work as well and as safely as the drugs on which they’re based.


On top of that, the number of companies manufacturing follow-on biologics will be much smaller due to the higher costs involved, including constructing factories, developing the drugs and conducting the trials. This probably will limit the number of manufacturers to those companies that already make follow-on biologics — including Teva, Sandoz and Hospira — and to companies with enough cash on hand to get into the business, like Mylan, which has expressed interest in biosimilars, and such branded drug companies as Merck and Pfizer.