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.
Industry advocates tout increase in generics use
Generic drug usage already has been on the rise year after year, with no sign of slowing down. As Jody Fisher, VP marketing for healthcare analytics at market research firm SDI, has told Drug Store News, generics accounted for more than 70% of products dispensed at retail pharmacies and are set to increase further this year.
But a recent recommendation by the Department of Health and Human Services could boost generics even more. In a document released earlier this month, HHS secretary Kathleen Sebelius urged governors of all 50 states to increase use of generics in state Medicaid programs, winning praise from such groups as the Pharmaceutical Care Management Association, a trade group representing pharmacy benefit managers. According to the Generic Pharmaceutical Association, Texas was able to save about $223 million by changing prescription pads to make it easier for doctors to prescribe generics, while federal and state governments together could save more than $2.9 billion per year with a 5% increase in generic utilization.
But generic drug makers could face some trouble as well, particularly with a bill proposed in early February by Sen. Patrick Leahy, D-Vt., which would make the biggest changes to patent laws in more than 60 years. While the GPhA and the Pharmaceutical Research and Manufacturers of America — the lobby that represents branded drug companies — both praised the bill on the whole, the GPhA expressed concerns about changes that it said could weaken the inequitable conduct provision, a provision that has enabled generic drug companies to challenge patents covering branded drugs. “We don’t think that patent reform should weaken the inequitable conduct provision,” GPhA interim executive director Bob Billings told DSN. “If it does, you’ll see slower times for generics to come to market.”
Currently, a patent can be ruled invalid in court if the court determines that the patent holder intentionally withheld information or deceived the Patent and Trademark Office. Generic drug companies wishing to launch before the branded version’s patent expires will include in their regulatory filing with the Food and Drug Administration a Paragraph IV certification, a legal assertion that the patent is invalid, unenforceable or won’t be infringed. If the judge can find inequitable conduct, the generic company can launch its version of the drug. Generally, the branded drug company will file a lawsuit, but in most cases, the two reach a settlement that still allows generic launch ahead of patent expiration.
ReportersNotebook — Chain Pharmacy, 2/28/11
SUPPLIER NEWS — Drug maker Valeant Pharmaceuticals International has acquired U.S. and Canadian rights to certain formulations of a GlaxoSmithKline drug used to treat cold sores. Valeant acquired the rights to nonophthalmic topical formulations of Zovirax (acyclovir) from GSK for $300 million through its Canadian subsidiary, Biovail Labs.
The Food and Drug Administration declined to approve a drug made by Eisai for treating gastroesophageal reflux disease, Eisai said. The drug maker announced its receipt of a complete response letter from the agency for its application for rabeprazole sodium extended-release capsules, a proton-pump inhibitor for GERD. The FDA delivers a complete response letter when it has finished reviewing a regulatory approval application, but issues remain that preclude final approval of the drug.
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The Food and Drug Administration approved Sun Pharmaceutical Industries’ generic version of Johnson & Johnson’s Alzheimer’s drug, Razadyne (galantamine hydrobromide) tablets. Razadyne has annual sales of about $50 million, according to Sun.