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 ...

The field is evolving—don’t get left behind. Expand your network and join 80+ structural biologists, medicinal chemists, ...

Japanese drug firm Chugai Pharmaceutical has established competitive advantages due to its alliance with majority shareholder Roche as well as its internal research and development engine. While ...

South Korea’s leading biosimilar drug developer Celltrion Inc. said on Monday it is set to sell Steqeyma, a biosimilar to ...

Boosting uptake of biosimilars will require practitioner change and a policy rethink, GBMA chair says Australia is “underdone on penetration in the market” when it comes to uptake of biosimilar ...

The politicization of the U.S. FTC continued March 18 with President Donald Trump firing the two remaining Democratic commissioners, Rebecca Kelly Slaughter and Alvaro Bedoya. The action leaves what’s ...

“The FDA's filing acceptance of Dr. Reddy's proposed denosumab biosimilar marks an important milestone in bringing this biosimilar medication to more patients throughout the U.S.,” said Milan ...

European Commission (EC) has approved Pfizer’s Trazimera, for breast and gastric cancer treatment, marking it as pharma’s first oncology biosimilar to receive approval in the EU.

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South Korea’s Celltrion (Kosdaq: 068270) has announced the US launch of Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab), following approval by the US Food and Drug Administration ...

Steqeyma is one of seven Stelara biosimilars that have been approved by the FDA. Celltrion has launched Steqeyma (ustekinumab-stba), its biosimilar of Stelara (ustekinumab), at list price at an 85% ...