A US district court has denied Johnson & Johnson’s motion to dismiss Pfizer’s Inflectra lawsuit, a case claiming anticompetitive practices blocked US uptake of the Remicade biosimilar.
A Phase I clinical trial to examine the safety and pharmacokinetics of BAT1806, an Actemra biosimilar, is to be conducted by Chinese pharmaceutical company Bio-Thera.
Just days after the release of its Biosimilar Action Plan to encourage generic competition, the US FDA has approved another biosimilar product: Pfizer’s answer to Amgen’s Neupogen, ‘Nivestym’.
Major pharmaceutical firms Novartis, Roche, and Pfizer have reacted to the US FDA’s Biosimilar Action Plan, which aims to “strike a balance” between innovation and market competition.
AbbVie’s mega-blockbuster Humira is facing biosimilar competition, but another patent licensing agreement, this time with Mylan, sees the company securing exclusivity through to 2023 in the US.
South Korea’s SFC has alleged that Samsung BioLogics had intentionally omitted information regarding the joint venture agreement with Biogen that created Samsung Bioepis.
The US FDA has issued a complete response letter to Amgen for its biosimilar version of Roche’s Herceptin, marking the agency’s third trastuzumab candidate rejection this year.
