Results released Friday show itepekimab succeeded in one Phase 3 trial but failed in a second, sinking shares of both partner ...

Since the European Medicines Agency (EMA) approval of omalizumab in 2005 as the first ever biologic for severe asthma, the ...

FDA biosimilar approvals reached a record 19 in 2024, with projections indicating that 2025 could surpass this milestone ...

Credit: House Ways and Means Committee Scientists are getting some of the most important new drugs from living organisms, but the patent rules and other rules for those "biologic" drugs are ...

JNJ's Simponi is approved in the United ... to expand the availability of high-quality biologic medicines. Given the high cost of branded drugs, a biosimilar alternative could provide substantial ...

Biologic drugs like Johnson & Johnson’s Stelara and Remicade ... recommending other options like Remicade, J&J’s Simponi, Takeda’s Entyvio, Gilead and Eisai’s Jyseleca or Eli Lilly’s Omvoh and others ...

Golimumab, a human monoclonal antibody, inhibits the biological activity of tumor necrosis factor alpha (TNF-alpha). The originator product, Simponi, is approved in ... expand at multiple levels ...

The FDA accepted the biologics license applications (BLA) for AVT05, Alvotech’s and Teva Pharmaceuticals’ proposed biosimilar to golimumab (Simponi and Simponi Aria ... plans to commercialize and ...

TEVA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Biologics License Applications (BLA) for AVT05, Alvotech’s proposed biosimilar to Simponi ® and Simponi ...

The FDA has accepted Alvotech (NASDAQ:ALVO) and Teva's (NYSE:TEVA) Biologics License Applications for AVT05, their proposed biosimilar to the anti-inflammatory drugs Simponi and Simponi Aria.

TEVA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Biologics License Applications (BLA) for AVT05, Alvotech’s proposed biosimilar to Simponi ® and ...

“He died from complications of ulcer and colitis after being treated with drugs ... The biologics include abatacept (Orencia), anakinra (Kineret), rituximab (Rituxan), tocilizumab (Actemra), ...