Prestige Biologics, a contract development and manufacturing organization (CDMO), announced it has signed a...
Prestige Biologics Partners with Dr. Reddy’s Laboratories Subsidiary in Strategic Manufacturing Collaboration
read more
Meitheal Pharmaceuticals Inks Deal with Tonghua Dongbao for US Insulin Biosimilars
Meitheal Pharmaceuticals announced an exclusive licensing agreement with Tonghua Dongbao Pharmaceutical to...
Abbott Partners with mAbxience to Commercialise Biosimilars
Abbott announced it has entered into a commercialisation agreement with mAbxience for several biosimilars focusing on...
First Biosimilar Approval Alert: Biocon Biologics’ Yesafili® Biosimilar to Regeneron’s Eylea® (aflibercept) Approved by EC
Biocon Biologics announced that Yesafili®, its biosimilar to Regeneron’s Eylea® (aflibercept), has received marketing...
Alvotech’s Resubmits BLA for AVT02, Interchangeable Biosimilar to AbbVie’s Humira® Accepted by FDA
On 20 September, Alvotech announced that the FDA has accepted its resubmitted Biologics License Application (BLA) for...
FDA Grants Priority Review for New KEYTRUDA® (pembrolizumab) Combo Treatment for Third Cervical Cancer Indication
Merck announced the US FDA accepted for priority review its supplemental Biologics License Application (sBLA) seeking...
BeiGene Regains Full Rights for Tevimbra® (tislelizumab) from Novartis
BeiGene announced it has regained worldwide rights to develop, manufacture, and commercialise Tevimbra® (tislelizumab)...
Approval Alert: EC Approves Fresenius Kabi’s Tyenne®, First Biosimilar to Roche’s Actemra® / RoActemra® (tocilizumab)
Fresenius Kabi announced that its Tyenne® (tocilizumab), biosimilar to Roche’s Actemra® / RoActemra® has been approved...
Rani Therapeutics Begins Ph I Clinical Trial of Oral Ustekinumab with Celltrion’s CT-P43
Korea Biomed reported that Rani Therapeutics has begun its phase I clinical trial for oral ustekinumab (RT-111) using...
Samsung Biologics and BMS Expand Manufacturing Agreement
Samsung Biologics announced a new agreement with Bristol Myers Squibb for large-scale manufacturing of a BMS antibody...
FDA Releases Draft Industry Guidance for Labeling for Biosimilar and Interchangeable Biosimilar Products
The FDA has released draft industry guidance for biosimilar and interchangeable biosimilar product labeling. The...
Celltrion to Supply Yuflyma®, Biosimilar to AbbVie’s Humira® (adalimumab), in Italy
KED Global reported that Celltrion won bids to supply Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), in five...
Novartis Shareholders Approve Sandoz Spin-Off
On 15 September 2023, Novartis shareholders approved the proposed Sandoz spin-off, Novartis’ generics and biosimilars...
CHMP Adopts Positive Opinion Of Sandoz’s Herwenda® (Trastuzumab) Biosimilar To Genentech’s Herceptin®
The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Sandoz’s Herwenda®...
CHMP Adopts Positive Opinion For Two Biosimilars, Three Innovator Biologics, Extends Indications for Six Other Biologics
On 15 September 2023, EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended Sandoz’s Herwenda®...
Biopharma Dominates November 2023 PBAC Agenda
According to the Pharmaceutical Benefits Assessment Committee (PBAC) November 2023 agenda published last week, the...