- Just days after the Food and Drug Administration issued its stance on approving complex generics more quickly, the agency did just that, giving the go-ahead to Mylan N.V.’s copycat version of the 40 mg/mL dose of Copaxone.
- Teva Pharmaceuticals Industries Ltd. has been staving off competition to its best-selling drug for years; first through legal battles, then by transitioning patients to a 40 mg/mL dose from a 20 mg/mL injection.
- Mylan also gained approval for a generic version of the 20 mg dose of the multiple sclerosis drug. But Novartis AG’s Sandoz beat them to that years ago with the approval of Glatopa in 2015.
Both of Mylan’s generic versions of Copaxone (glatiramer acetate) are considered substitutable. Mylan also noted that it could (along with any other generic versions that get approved) have a 180-day exclusivity period.
"As part of its ANDAs, Mylan submitted rigorous side-by-side analyses, including characterization data, which demonstrated that Mylan's Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL have the same active ingredient, dosage form, route of administration and strength as their branded counterpart," wrote Mylan in a statement.
The approval is a major win for the generic drugmaker, which has come under fire this year for the pricing of its best-selling product, the allergy treatment EpiPen. The company’s stock was up more than 5% in early morning trading on the NASDAQ on Wednesday.
"Mylan has invested tens of millions of dollars over many years to bring this important medicine to market," said Mylan CEO Heather Bresch in a statement.
Mylan is expected to launch the copycat immediately, but the company did not respond to inquiries about the price of the generic by the time of publication. While both Sandoz and Dr. Reddy’s Laboratories are developing generic versions of the drug as well, neither is expected to get approval in the next six months. Sandoz is currently trying to remedy a Complete Response Letter related to manufacturing issues for the drug.
Meanwhile, Teva fell nearly 13% as shares sunk to about $16.50 apiece, well below its 52-week high of $49.99. Copaxone has long been the company's best-selling product, bringing in nearly $700 million for the 20 mg/mL dose and $3.64 billion for the 40 mg/mL dose during the 12 months ended July 2017. The company managed to curtail a loss of revenue upon the entrance of Glatopa to the market by shifting patients over to the 40 mg/mL dose.
Consensus estimates from analysts project Teva Copaxone revenues dropping approximately 9% in 2017 and as much as 39% in 2018.
The Israeli drugmaker has been struggling for the better part of five years now as its shareholders have watched a revolving door of CEOs come in and out of the company. Most recently, former Novo Nordisk A/S vet and Lundbeck A/S CEO Kåre Schultz has signed on to the top slot.
Schultz’s first action has been to start dramatically reducing the debt load at the company; Teva has more than $35 billion in debt after buying Allergan’s generics unit last year.
The company has had a fire sale of assets, including the sell off of its women’s health business to multiple different players.