FDA Law Blog: Biosimilars

DECEMBER 11, 2023

FDA’s assumption that 50% of the tests will be exempt is particularly baffling because the laboratories are ones licensed to perform high complexity tests. In seeking to justify regulation of LDTs, FDA emphasizes that many of these tests are novel. [6] By their very nature, these tests are less likely to be exempt from FDA review.

FDA 69

FDA Laboratories Regulations Production 69

The Pharma Data

FEBRUARY 8, 2021

District Court for the District of Delaware asserting two method of use patents (US 10,583,110 and US 10, 716,777), both of which lasts until October 2030. In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. Plavix ® sales were down 1.4%

Vaccine 52

Vaccine Production FDA Pharmaceuticals 52

The Pharma Data

FEBRUARY 4, 2021

District Court for the District of Delaware asserting two method of use patents (US 10,583,110 and US 10, 716,777), both of which lasts until October 2030. In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. Plavix ® sales were down 1.4%

Vaccine 52

Vaccine Production FDA Pharmaceuticals 52

The Pharma Data

APRIL 27, 2021

District Court for the District of Delaware asserting two method of use patents (US 10,583,110 and US 10, 716,777), both of which expire in October 2030. net price, increasing usage of Toujeo ® , biosimilar glargine competition and lower sales in Europe (patient stockpilling in the first quarter of 2020). In the U.S., Collaborations.

Vaccine 52

Vaccine Production FDA FDA Approval 52