DISEASE CATEGORY: Autoimmune disease INDICATION: Rheumatoid arthritis (RA) Inhibiting the lactate transporter SLC5A12 could treat RA. In 87 patients with early RA, high levels of SLC5A12 RNA expression in the synovium was associated with increased...

Ten years after the U.S. created a pathway for biosimilars--and four and a half years after the first FDA approval--a few manufacturers have demonstrated that they can overcome the technical, regulatory and commercial barriers to...

As it continues to rely on biosimilars as a growth driver, Biogen has expanded its deal with Samsung Bioepis to include two new ocular biosimilars in certain major markets, as well as rights in China...

Phathom, Galera move toward listings  Phathom Pharmaceuticals Inc. proposed terms for an IPO on NASDAQ. The GI company proposed to sell 7.9 million shares at $18-$20; at the mid-point, it would raise $150.1 million at...

Amgen, Allergan launch pair of biosimilars  Amgen Inc. (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) launched Mvasi bevacizumab-awwb and Kanjinti trastuzumab-anns in the U.S.; they are the first biosimilars of Avastin bevacizumab and Herceptin trastuzumab available in...

Frustration over the failure of biosimilars to slash the costs of decades-old biologics has prompted a group of policy analysts to suggest abandoning attempts to copy biologics. Because the sole purpose of biosimilars is to...

The U.S. biosimilars market lags Europe’s and won’t catch up until physicians understand and become comfortable with the concept of similarity, Sheila Frame, who heads up Sandoz’s North American biosimilars business, told BioCentury. To create...

Seven pharma leaders expressed strong support for eliminating rebates to PBMs and insurance companies, shifting from volume- to value-based reimbursement, and reducing out-of-pocket costs for drugs in testimony Tuesday to the Senate Finance Committee. The...

Merck & Co. Inc. (NYSE:MRK) said President of Global Human Health Adam Schechter will step down at the end of the year. The company will restructure his former position into two new roles effective Jan....

A group of biosimilar manufacturers including Pfizer Inc. (NYSE:PFE) urged FDA to produce supplemental guidance clarifying how to comply with existing law when communicating about biosimilars. The Biosimilars Forum sent its plea in a letter...