Impax granted FDA approval for generic Adoxa
HAYWARD, Calif. — Impax Labs received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment.
The drug maker on Friday said it received final approval of its abbreviated new drug application for doxycyline monohydrate capsules in the 150-mg strength. The drug, which is a tetracycline antibiotic used to treat bacterial infections, is a generic version of Adoxa. Adoxa is manufactured by PharmDerm, a Nycomed subsidiary.
Impax said its generic division, Global Pharmaceuticals, will launch the product.
U.S. sales of Adoxa in the 150-mg strength were approximately $25 million in the 12 months ended in December 2010, according to Wolters Kluwer.
As innovaters prep for patent cliff, generics prosper from patent losses
A whole slew of drugs will lose patent protection this year, opening up opportunities for generic drug makers to market their own versions. Most notable among these is Pfizer’s cholesterol- lowering drug Lipitor (atorvastatin), the world’s top-selling drug, with U.S. sales of $7 billion during the 12 months ended September 2010, according to IMS Health.
Other important drugs facing generic competition over the next few years include the cardiovascular drug Plavix (clopidogrel) by Sanofi-Aventis and Bristol-Myers Squibb, and Eli Lilly schizophrenia and bipolar disorder drug Zyprexa (olanzapine), which had annual sales of $5.8 billion and $2.8 billion during the 12 months ended September 2010, respectively. Though Sanofi and BMS recently scored a victory when the Food and Drug Administration extended the pediatric exclusivity period for Plavix until 2012, the party will soon be over, or it will at least wind down a bit.
The year 2014 marks the patent cliff, at which point most of the top-selling drugs will have lost patent protection. Generic drug companies have grown significantly on the strength of generic versions of blockbuster drugs, but after 180 days of market exclusivity in which to compete with the branded version, a molecule becomes fair game for any generic manufacturer, thus commoditizing it so much that the innovator sometimes has to pull the branded version from the market.
While branded and generic drug companies alike have sought refuge in biologics and follow-on biologics, the market for drugs to treat such widespread conditions as cardiovascular disease won’t necessarily go dry. According to a recent report by the Pharmaceutical Research and Manufacturers of America, 299 drugs are in development for treating cardiovascular disease, with 16 applications filed with the FDA seeking approvals for new drugs or new uses for existing drugs. Perhaps amid those 299 drugs lie some blockbusters to be.
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.