FDA Law Blog: Biosimilars

MARCH 18, 2025

Merck applied for a patent term extension on the reissued patent, claiming the start of the regulatory review period as April 2004 and termination at the approval of the BRIDION NDA in December 2015. With this long regulatory review period, the PTO granted the statutory-maximum five-year patent term extension. The plain text of 35 U.S.C.

Drug Pricing 59

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies 59

European Pharmaceutical Review

JULY 4, 2024

4,6 Five patent issues that European biosimilar developers should consider before entering the US market Quality control of the botanical drug substances was one of the critical factors that led to barricades during the development of Veregen and Mytesi. Navigating Market Authorisation in the UK for the Pharmaceutical Industry [Internet].

Drug Development 103

Drug Development Biosimilars Documentation Labelling 103

PharmaShots

APRIL 13, 2023

model is a holistic approach to incorporate the same strategy to life science and pharmaceutical companies. A globally fast-growing, and largest pharmaceutical company in the world was created through a merger between Pfizer and Pharmacia. Following its patent expiry, Cipro’s sales in the year 2004 declined by 12.9%

Biosimilars 40

Biosimilars Vaccines Pharmaceutical Companies Pharmaceutical Companies 40

Pharmaceutical Technology

APRIL 12, 2023

This is to ensure patient safety, as outlined in The Medicines for Human Use (Clinical Trials) Regulations 2004. It stated that in vivo animal studies were not necessary for showing comparability between a biosimilar candidate and its reference medicinal product. This approach to more pragmatic regulation is also trending globally.

Vaccines 98

Vaccines Biosimilars Communication Pharmaceutical Companies 98