The APPA, if passed into law, puts an upper limit of 20 patents, but only of certain types of patents (see below), that can be asserted in a BPCIA litigation (the APPA does not affect ANDA litigations ...

More ‘biosimilar’ medicines should be brought to market in the EU because of a regulatory policy shift on the need to carry out expensive clinical efficacy studies, experts have said.

Biosimilars and biobetters present a lucrative ... His responsibilities at Roche involved the design and implementation of development strategies for numerous novel chemical entities (NCE ...

A Sanofi subsidiary has claimed FDA approval for the first biosimilar of Novo Nordisk's Novolog, an older formulation of the Danish pharma's blockbuster insulin analogue product insulin aspart.

"Regeneron has invested many years of effort into its design and development of EYLEA ... court decision on appeal and remove Amgen's biosimilar product from the market, so as such this news ...

At the same time, 90% of U.S. prescriptions are either generics or biosimilars saving the U.S. healthcare system $445 billion in 2023 alone. Despite these achievements, there are important reforms ...

The biosimilar approval was based on a comprehensive clinical data package, which included a double-blind, randomized, active-controlled phase 3 trial (ClinicalTrials.gov Identifier: NCT04757376 ...

It generates roughly 75% of sales from generic drugs with the remainder from biosimilars and has a significant presence in Europe, a region that generates around half of its total sales.

Alvotech acquires Xbrane's R&D operations and biosimilar candidate XB003 for ~$27M, expanding into Sweden's life sciences sector. Xbrane retains key preclinical assets, strengthens finances ...

Omlyclo is the first interchangeable biosimilar to omalizumab (Xolair; Genentech, Novartis). Omlyclo was approved to treat the same conditions as Xolair. The FDA approved Celltrion’s omalizumab ...