The US Food and Drug Administration (FDA) has upgraded the status of Pfizer’s fill/finish manufacturing facility in McPherson, Kansas. Pfizer received a Warning Letter in 2017 following an FDA inspection of the facility. The upgraded status lifts a compliance hold on approval of pending applications of products made at the facility. Pfizer provided an update of the status in its 2017 financial results, which were released on January 30, 2018.  

The FDA issued a Warning Letter to Pfizer in February 2017 following a routine FDA inspection of the company’s facility in McPherson, Kansas in 2016. Pfizer submitted a corrective and preventative action plan to the FDA in March 2017. In January 2018, the FDA upgraded the status of Pfizer’s McPherson, Kansas manufacturing facility to Voluntary Action Indicated (VAI) based on an October 2017 inspection. According to the FDA, VAI status concludes that objectionable conditions were found and documented, but the center is not prepared to take or recommend any further regulatory (advisory, administrative, or judicial) action because the objectionable conditions do not meet the threshold for regulatory action. “The change to VAI status will lift the compliance hold that the FDA placed on approval of pending applications and is an important step toward resolving the issues cited in the February 2017 FDA Warning Letter,” Pfizer said in its fourth-quarter and full-year 2017 earnings report. Pfizer gained the McPherson facility from its $17-billion acquisition of Hospira in 2015.

The upgraded status is important for consideration of pending applications for products made at the facility. In June 2017, the FDA issued a Complete Response Letter (CRL) to Pfizer regarding its biologics license application (BLA) for its proposed epoetin alfa biosimilar over manufacturing issues. The CRL related to matters noted in the February 2017 Warning Letter.The facility was listed as the potential manufacturing site in the BLA for the proposed epoetin alfa biosimilar. In May 2017, the FDA Oncologic Drugs Advisory Committee (ODAC) voted to recommend Pfizer’s proposed biosimilar for approval.

In February 2017, Momenta Pharmaceuticals, a Cambridge, Massachusetts-based biotechnology company, which is partnered with Sandoz, the generic-drug arm of Novartis, for Glatopa (glatiramer acetate injection), a generic version of Teva Pharmaceutical Industries’ multiple sclerosis drug, Copaxone (glatiramer acetate injection), reported a delay in the regulatory review of a 40-mg formulation of the drug due to manufacturing issues of Pfizer, the contract manufacturer of the fill/finish of the product. Momenta was informed in 2017 by Pfizer, Sandoz’s contracted fill/-finish manufacturing partner for Glatopa, that it had received a Warning Letter from the FDA relating to the 2016 FDA inspection of Pfizer’s fill/finish facility in McPherson, Kansas.

“The Glatopa 40 mg ANDA [abbreviated new drug application] remains under regulatory review; however, the company believes the application review could be completed at any time in connection with the change to VAI status,” Momenta said in a January 30, 2018 company statement. “We are extremely pleased with this outcome. This past year of uncertainty regarding the resolution of the McPherson facility Warning Letter has been difficult for Momenta and its shareholders, but with this announced change in status we believe we are well-positioned to gain marketing approval and launch our Glatopa 40 mg in the first half of 2018,” said Craig Wheeler, Momenta chief executive officer, in the statement. 

In 2015, Novartis’ generics arm, Sandoz, launched a 20-mg formulation of a generic form of Copaxone, and Momenta and Sandoz filed an abbreviated new drug application (ANDA) with the FDA for the 40-mg formulation of the drug. Teva successfully applied a generic defense strategy for Copaxone when it launched the 40-mg/mL formulation of the product with a three-times a week dosing regimen following the patent expiration of a first-generation 20-mg/mL formulation with more frequent dosing. Patents covering for Copaxone 20 mg/mL expired in May 2014, and in most of the rest of the world in May 2015. Teva launched the 40-mg/mL formulation of Copaxone in the US in January 2014, and it was approved in Europe in December 2015. Copaxone is a top-selling drug for Teva with 2017 sales of $3.8 billion.

Source: Pfizer (2017 earnings report) and Momenta Pharmaceuticals