Before lengthy legal battles between Teva Pharmaceuticals and drug manufacturers eager to claim a portion of the lucrative MS drug market have been completely resolved, the FDA announced late on Thursday, April 16, 2015, approval of the first generic version of Copaxone (glatiramer acetate injection).
Sandoz, a subsidiary of Novartis, has received FDA approval to market Glatopa, a generic version of glatiramer acetate in a 20 mg/ml daily injection. Developed in collaboration with Momenta Pharmaceuticals and produced entirely in the US, Glatopa is indicated for the treatment of patients with relapsing forms of MS, including patients with clinically isolated syndrome.
Mylan Inc, in collaboration with Natco Pharma Ltd, is also working on generic versions of Copaxone. I say versions, plural, because last August 2014, Mylan, Momenta and Sandoz announced that the FDA had accepted their ANDAs (abbreviated new drug application) for three-times-a-week generic Copaxone.
Higher-dose, lower-frequency Copaxone
In anticipation of losing patent protection for daily Copaxone in September 2015, Teva developed a more concentrated version, injected three-times-a-week in a 40 mg/ml dose. FDA approved the higher dose Copaxone in January 2014.
Teva began the long process of encouraging as many customers as possible to switch to the 40mg/ml dose over the past 14 months. Current estimates are that approximately 65% of Copaxone customers are now using the higher-dose, lower-frequency formulation. However, some MS patients in forums have reported increased side effects with the higher dose and made the switch back to daily Copaxone injections.
“Health care professionals and patients can be assured that FDA-approved generic drugs have met the same rigorous standards of quality as the brand-name drug,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Before approving [Glatopa], given its complexity, we reviewed additional information to make sure that the generic product is as safe and effective as the brand name product.”
Momenta Pharmaceuticals also announced the upcoming presentation of two posters comparing gene expression profiles and additional methods used to show equivalence between Glatopa and daily Copaxone 20 mg (glatiramer acetate injection). The posters will be presented at the 67th American Academy of Neurology (AAN) 2015 Annual Meeting which began today in Washington, DC, and continues through April 25, 2015.
- Title: Comparative Gene Expression Profiling between a Generic (Glatopa) and Brand COPAXONE (glatiramer acetate injection); Poster Number: P1.144; Presentation Date/Time: Monday, April 20, 2015; 2:00 p.m. – 6:30 p.m. EDT
- Title: Demonstration of Equivalence between a Generic (Glatopa) and Brand COPAXONE (glatiramer acetate injection); Poster Number: P1.145; Presentation Date/Time: Monday, April 20, 2015; 2:00 p.m. – 6:30 p.m. EDT
Availability and affordability
While we know that Glatopa will become the third MS drug in the Novartis franchise, we do not know when Glatopa will be available to patients. It might be smart for Momenta and Sandoz to wait until September when relevant patents expire to avoid owing reparations if Teva’s final court appeal is ruled in their favor.
As for cost, Momenta and Sandoz did not disclose pricing strategy in advance of the drug launch. The price of a one-month supply of daily Copaxone 20 mg/ml pre-filled syringes ranges from $6200 to $6700 (with coupon, at stores near my zip code) according to GoodRX.com. A one-month supply of Copaxone 40 mg/ml pre-filled syringes is slightly less, ranging from $5100 to $5400. Of course, many patients covered by insurance and copay assistance do not pay the full price.
When Glatopa becomes available, will you be interested in switching to the generic version?** See More Helpful Posts:**
FDA approves first generic Copaxone to treat multiple sclerosis. FDA News Release. Apr 16, 2015.
FDA approves 3-times-a-Week Copaxone in MS. Medscape. Jan 29, 2014.
Momenta Pharmaceuticals Announces Data Presentations on Glatopa(TM) (glatiramer acetate injection) at the American Academy of Neurology's (AAN) 2015 Annual Meeting. Momenta Press Release. Apr 17, 2015.
Mylan, Momenta, Sandoz join assault on Teva's new-and-improved Copaxone. FiercePharma. Aug 28, 2014.
Sandoz receives FDA approval for GLATOPA™ as the first generic competitor to MS therapy COPAXONE® 20MG. Sandoz Press Release. Apr 16, 2015.