Eye on Pharma: Lupin Pharmaceuticals Announces Biosimilar Development Plans

At the J.P. Morgan Healthcare conference, Lupin Pharmaceuticals, a subsidiary of India-based Lupin Limited, announced biosimilar development plans for the company.

Lupin said that it is setting a target date to file regulatory applications for biosimilar etanercept (referenced on Amgen’s Enbrel) in the first quarter of 2019’s fiscal year in Europe, and in the third quarter of 2020’s fiscal year in the United States.

Looking farther in Lupin’s biosimilar pipeline, ranibizumab is currently in phase 1 clinical trials, while pegfilgrastim, filgrastim, denosumab, pertuzumab, and afliberept are all in early stages of development.

Lupin also discussed its goal of putting a stronger emphasis on addressing the $54 billion complex generic drugs market as it tries to set itself apart from the growing competition around branded drugs. In this respect, it is focusing efforts on developing its inhaled drug pipeline, worth $17 billion, in the next 3 years. Lupin also announced that it is in discussions with the FDA to explore opportunities to accelerate the development timeline for such programs. Lupin expects its complex generic portfolio to begin contributing to its yearly earnings growth starting in fiscal years 2018 to 2020.

The company also said that it is focusing on getting 2 of its plants, located in Goa and Indore, up to code after they received warning letters from the FDA in November 2017 for deviation in good manufacturing practices.

Issues observed include failure to thoroughly investigate unexplained discrepancies or failures of a batch or any of its components to meet any specifications and failure to establish appropriate time limits for the completion of each phase of production to assure the quality of the drug product.

In order to become compliant, the FDA has recommended that a current good manufacturing practice consultant be hired to comprehensively assess the manufacturing processes and laboratory systems.