New Dosage by Teva
Teva has been preparing for the entry of generics with a new dosage of three-times-a-week.
In May 2013, Teva announced FDA acceptance of sNDA for Copaxone 40mg/ 1mL, a higher concentration dose of COPAXONE® that offers a less frequent three times a week dosing regimen.
Teva received the approval in January 2014 as previously mention in Copaxone’s history.
In 2015 first quarterly report, Teva said Copaxone® 40 mg/mL accounted for 66% of total Copaxone® prescriptions in the U.S. And the US sales decline compared with 2014 Q1 mainly reflects unusually strong sales in the first quarter of 2014 due to inventory stocking in connection with the launch of Copaxone® 40 mg/mL in January 2014.
First Generic
First generic of Copaxone, Glatopa, was proved in April 16, 2015.
The approval is for glatiramer acetate in 20 mg/ml daily injections.
Glatopa was developed by Momenta Pharmaceuticals and marketed by Sandoz, a Novartis company.
One month later, the Sandoz launched the drug in the US.
First 40mg/ml Generic Approval
In October 2017, Mylan received the long-waited approval for both dosage versions. Mylan also confirmed the launch in US one day after.
Shares in the Israeli company (Teva) were down 13% this morning – many were not expecting the FDA verdict until next year. Umer Raffat at Evercore ISI attempted to quantify the damage: earlier than expected loss of revenues could result in an annualised $480m to $640m being shaved from consensus operating profit estimates, he believes. [EvaluatePharma]
It’s a major lift for Mylan, whose anticipated 20-mg knockoff of the multiple sclerosis star has been conspicuously missing for years. A team of Novartis’ Sandoz and Momenta zoomed ahead with an April 2015 approval of their own version, Glatopa, which last year helped Sandoz’s biopharmaceuticals unit grow 25% to $772 million in sales. [FiercePharma]
According to the FDA approval letter, Mylan was one of the first applicants to submit a substantially complete ANDA for Glatiramer Acetate Injection, 40 mg/mL, containing a Paragraph IV certification. Therefore, Mylan and other first filers may be eligible for 180 days of generic drug exclusivity but FDA has not made a formal determination on exclusivity at this time.
Notably, the approval for Mylan comes a day after the FDA commissioner, Scott Gottlieb, released draft guidance to help speed the approval of complex generics like Copaxone. If any were needed, this earlier than expected green light provides further evidence that the US regulator is determined in its efforts to smooth the path to market for a wider range of copycat medicines.
