Momenta Receives Warning Letter for Generic Copaxone

In a press release, Momenta announced on Feb. 16, 2017 that Momenta/Sandoz’s fill/finish contract manufacturer, Pfizer, received a warning letter for the manufacture of the 40 mg of Glatopa (glatiramer acetate injection), Momenta’s generic version of the drug Copaxone. Pfizer said in the statement that the warning letter does not affect the production or shipment of the 20 mg version of the drug, which is already approved by FDA. The 40-mg version of the drug is still being evaluated by FDA.

The Momenta release stated, “under FDA policy, an approval of the application is dependent on the satisfactory resolution of the compliance observations at the Pfizer facility used to make the final product, and Momenta expects that an approval in the first quarter of 2017 is unlikely.”

Although there are multiple contenders vying to make generic Copaxone, the 20-mg version made by Momenta is currently the only dosage and version that has been approved.

Pfizer said the plant that received a warning letter was in McPherson, Kansas. The plant was a former Hospira plant that had received Form 483s in the past. In an email to this publication, Pfizer said, "We responded to the questions raised during the inspection of our manufacturing site in May 2016 and submitted a corrective and preventive action plan to the FDA at that time. Since the inspection, the McPherson site has been diligently implementing commitments made to the FDA. We will continue to identify assessments and potential corrective actions to ensure the FDA’s observations are addressed."

The Pfizer spokesperson continued, "We also have conducted an assessment and concluded that the issues cited in the Warning Letter do not have any impact on products that are currently on the market that were manufactured at the McPherson site."   Meanwhile, on Feb. 16, 2017, a day before Momenta formally recognized the warning letter, Pfizer CentreOne

announced

it has expanded its fill/finish capabilities to its Kalamazoo, MI site. The site will now handle sterile injectables.

Source: Momenta

*Updated to include comments from Pfizer