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Samsung Bioepis presented new data on its SB16 (denosumab, biosimilar to Amgen’s Prolia®) at the American Society for Bone and Mineral Research (ASBMR) 2023 Annual Meeting being held from October 13 to 16 in Vancouver, BC, Canada.  The SB16 ph I and III studies demonstrate ...

An AbbVie sponsored phase 3 study evaluating risankizumab for treatment of Crohn’s disease shows that risankizumab performs better than ustekinumab in primary and secondary endpoints. The study compared risankizumab to ustekinumab for the treatment of adult patients w...

A new study abstract published in United European Gastroenterology concluded that patients who switched from Celltrion’s Remsima® (CT-P13) to Samsung Bioepis’ Flixabi®/Reflexis® (SB2), both biosimilars to Janssen’s Remicade® (infliximab) was safe, did not significantly affe...

MSD announced that it received a positive recommendation from EMA’s CHMP for the approval of Keytruda® (pembrolizumab) in combination with fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of locally advanced unresectable or metastatic human e...

Dr Reddy’s informed the Indian National Stock exchange on 12 October 2023 that the FDA issued a Form 483 with nine observations for Dr Reddy’s biologics manufacturing facility in Hyderabad.  The observations were issued after a product-specific pre-approval inspection of th...

Prince Edward Island announced implementation of a biosimilar switching policy consistent with ten other provinces in Canada.  From 12 October 2023, patients covered under PEI Pharmacare program will begin switching biosimilars. Pharmacare beneficiaries will have until 30 J...

Alvotech announced that FDA has issued a Complete Response Letter (CRL) regarding its aBLA for AVT04, biosimilar to Janssen’s Stelara® (ustekinumab).  The letter relates to certain deficiencies that were conveyed following the FDA’s inspection of Alvotech’s Reykjavik facili...

Amneal Pharmaceuticals, Inc announced that it has added two denosumab products (biosimilars to Amgen’s Prolia® and Xgeva®) to its biosimilar pipeline.  The denosumab products are being developed by mAbxience.  MAbxience is responsibility for development and manufacture and ...