ClinicSpeak: generic glatiramer acetate and more pharma shenanigans

How loyal will MSers be to Copaxone, the brand? #ClinicSpeak #MSBlog #MSResearch

"This is probably old news for you, but the FDA licensed a generic version of glatiramer acetate last week. The excerpts from the press article below cover the most important issues." 

"It is interesting to note that because of an ongoing patent dispute the actual launch of the generic version of GA will be delayed. Momenta and Sandoz, who will co-market the generic GA, have been in numerous court battles with Teva who make Copaxone. Momenta and Sandoz are trying to invalidate a patent held by Teva which expires in September 2015. If Momenta and Sandoz  launch the generic GA before September, they risk a court decision that would force them to remove the drug from the market and a counter-claim from TEVA for loss of revenue due to the illegal competition. In the meantime, my US colleagues are telling me that Teva are frantically trying to switch all US MSers on Copaxone from their original 20-mg daily formulation to the new 40-mg three times a week formulation. The latter formulation has patent protection until 2028. It is clear that TEVA want to retain as many of MSers on their product as possible to maintain their revenue stream."

"The same issues are likely to arise in Europe. It is interesting that with biologicals the issues are different. Even if biologics come off patent it is very costly and difficult to get a biosimilar licensed. This is why the majority of top earning drugs are now biologicals and why Pharma now favours biologics over small molecules. The latter are easy to copy. Any guesses how much generic GA will cost compared to Copaxone? When small molecules come of patent the price of generics are typically 90% cheaper within 2 years. With biosimilars the drop is only about 30%. GA is not really a small molecule, or a biologic, but I guess due to the manufacturing issues it will probably behave in a similar way to and hence I predict the generic version will probably be about 30% cheaper. Let's wait and see. I sincerely hope this is not the case in the developing world where MSers are in desperate need for cheap and effective DMTs."

"Another issue is brand loyalty. On my recent trip to India I was horrified that Indian Neurologists favoured Rituxan (rituximab) over the Indian biosimilar Reditux, which cost a third of the price of the innovator product. They simply felt the innovator compound was superior despite data showing similar levels of peripheral B cell depletion. When I told my wife this story she said why was I surprised, I should never underestimate the power of the brand. Generic GA will be a test of how powerful Copaxone is as a brand. I would be interested to hear from any MSers out there who are on GA  how they would feel being switched from Copaxone, a brand they know and trust, to cheaper generic version?"
   

Robert Weisman. First generic drug for multiple sclerosis approved. The Boston Globe APRIL 16, 2015

Excerpts:

.... Federal regulators ...... approved the first generic MS therapy, a development that could drop the price of the drug for consumers and boost the business of Momenta Pharmaceuticals Inc., which produced the injectable treatment.....

...... The generic version of the MS drug Copaxone will be sold under the brand name Glatopa by the Sandoz division of Switzerland’s Novartis AG, which signed an agreement with Cambridge-based Momenta to market the generic.....

..... Glatopa was approved as a “substitutable generic" for patients taking Copaxone, an injectable sold by Israel's Teva Pharmaceutical Industries Ltd. for MS, a degenerative disease of the central nervous system. “Given its complexity, we reviewed additional information to make sure the generic product is as safe and effective as the brand-name product,” said Janet Woodcock, director of the Food and Drug Administration’s drug evaluation unit......

..... Sandoz and Momenta have not disclosed when they will launch Glatopa commercially in the United States or how it will be priced in relation to Copaxone, which competes with such MS drugs as Avonex from Biogen Inc. of Cambridge and Rebif from EMD Serono Inc. of Rockland.....

..... The list price for a year’s worth of Copaxone, which is injected daily, is more than $60,000 per patient. Insurers cover the bulk of the cost for most patients.......

...... “We won’t discuss our pricing strategies publicly ahead of launch but our general goal, as always, would be to offer patients and payers a real alternative to the originator,” said Julie Masow, a spokeswoman for Novartis.....

..... A long-running patent dispute pitting Teva against Sandoz and Momenta is working its way through the federal courts, but it’s not clear if that will delay the launch....

CoI: multiple

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