A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from Mylan and Biocon.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, August 30, 2017 to Tuesday, September 5, 2017.

Mylan’s, Biocon’s Herceptin Biosimilar Delayed by FDA
The US Food and Drug Administration (FDA) has extended its target action date by three months for the biologics license application for a biosimilar of trastuzumab from Mylan and Biocon, a Bangalore, India-based pharmaceutical company. Herceptin is a top-selling drug for Roche with 2016 sales of CHF 6.78 billion ($7.04 billion).

The FDA ordered the three-month extension in order to review some of the clarificatory information submitted to it as a part of the application-review process, according to Biocon. Biocon says the extension has no impact on the anticipated timetable for commercialization of the product in the US. In July 2017, a FDA advisory committee recommended Biocon’s and Mylan’s trastuzumab biosimilar for approval.

Biocon and Mylan are partnered for the development and commercialization of six biosimilars, including trastuzumab. The companies suffered a setback in July 2017 when Biocon was cited by French regulatory authorities for good manufacturing practice deficiencies in a drug-product manufacturing plant that was to make pending biosimilars, including trastuzumab and pegfilgrastim, a biosimilar to Amgen’s Neulasta, a drug to stimulate white-blood cell production after chemotherapy. While European regulatory authorities approved the drug-substance facilities for manufacturing trastuzumab and pegfilgrastim, regulators informed the company that there is need for a reinspection of its drug-product manufacturing facility. In August 2017, Biocon said it plans to resubmit its marketing authorization application to European regulatory authorities for these biosimilars pending corrective actions. It further said that it is on track to complete the corrective and preventive actions at its drug-product manufacturing facility by the end of the third quarter of 2017 and intends to seek reinspection and resubmission thereafter.

Source: Biocon

Lilly to Resubmit NDA to FDA for Arthritis Drug
Eli Lilly and Company and Incyte Corporation, a Wilmington, Delaware-based biopharmaceutical company, plan to resubmit a new drug application (NDA) for their rheumatoid arthritis drug, baricitinib, to the US Food and Drug Administration (FDA) before the end of January 2018. Prior to certain delays, the drug had been projected for blockbuster status by some analysts.

Lilly and Incyte reported in July 2017 that the resubmission of their NDA would be delayed beyond 2017. This was the second recent setback for baricitinib. In April 2017, the companies received a Complete Response Letter from the FDA seeking additional clinical data to determine the most appropriate doses of the drug and to further characterize safety concerns across treatment arms. Lilly and Incyte submitted the NDA for baricitinib to the FDA in January 2016, and in January 2017 announced that the FDA had provided a three-month extension at that time to allow time for review of additional data analyses.

The 2018 resubmission package will include new safety and efficacy data. The companies anticipate the FDA will classify the application as a Class II resubmission, which will start a new six-month review cycle.

Baricitinib is a once-daily oral janus kinase inhibitor in clinical studies for inflammatory and autoimmune diseases. Based on an anticipated 2017 market launch, Clarviate Analytics had projected 2021 sales of nearly $1.3 billion.

Source: Eli Lilly and Company

Bayer Submits BLA for Hemophilia A Drug
Bayer has submitted a biologics license application (BLA) to the US Food and Drug Administration for its long-acting. site-specific PEGylated recombinant human Factor VIII (BAY94-9027) for treating hemophilia A.

Source: Bayer

Cellectis Puts Gene Therapy on Clinical Hold Following Patient Death
Cellectis, a New York headquartered clinical-stage biopharmaceutical company focused on immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), has received a notice of clinical hold from the US Food and Drug Administration (FDA).

The agency placed a hold on both UCART123 ongoing Phase I studies, respectively in acute myeloid leukemia and in blastic plasmacytoid dendritic cell neoplasm (BPDCN). The clinical hold was initiated after Cellectis reported one fatality in the BPDCN clinical trial.

Cellectis said it is working closely with the investigators and the FDA in order to resume the trials with an amended protocol, including a lowered dosing of UCART123.

Source: Cellectis