Monoclonal antibodies lead biosimilar approvals because of their large market size, well-defined regulatory pathways, and ...

This article is authored by Dr YK Gupta, president, AIIMS, Jammu and Ankush Kapoor, founder & CEO, Pharma NXT Biotech.

Biosimilars are essential healthcare equalizers, but their regulation is overly complicated due to lobbying by makers of ...

After approval by the FDA, AVT03 is expected to be supplied in a single-dose prefilled syringe containing 60 mg in a 1 ml ...

The label expansion could help J&J establish Tremfya as a successor to Stelara, which is now facing a growing biosimilar ...

South Korean biotech firms are targeting the $26 billion biosimilar market opening up as patents expire on more than 10 ...

Overall, the study’s findings support the use of Amjevita and Imraldi as equally effective alternatives to Humira in the real ...

Alvotech acquires Xbrane’s R&D operations and the biosimilar candidate XB003. Xbrane retains some pre-clinical development programs, that it intends to commercialize, and will continue operating as a ...

Dr. Reddy’s Laboratories (RDY) and Alvotech (ALVO) announced that the U.S. FDA has accepted a Biologic License Application submission for AVT03. Read more here.

Steqeyma is indicated for the treatment of plaque psoriasis and psoriatic arthritis in adult and pediatric patients, as well ...

“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 ...

Dr. Reddy’s Laboratories (RDY) and Alvotech (ALVO) announced that the U.S. Food and Drug Administration, FDA, has accepted a 351(k) Biologic ...