What’s Next? Five Things To Look Out For In October
Reddy’s Looks To FDA NuvaRing Response; Q3 Results Hit The Market
In October, Dr Reddy’s Laboratories and ANI Pharmaceuticals are among companies expecting to hear from the US Food and Drug Administration for key applications, as the annual joint conference of Medicines for Europe and the International Generic and Biosimilar medicines Association takes place in Athens, Greece.
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FDA Approves First Ophthalmic Biosimilar With Samsung Bioepis’ Lucentis Rival
Samsung Bioepis has celebrated the FDA’s first ever approval of an ophthalmic biosimilar with its endorsement of the firm’s Byooviz ranibizumab rival to Lucentis. The firm has also signaled a surprising expected launch date in the US, as well as offering expectations for launch in Europe where the biosimilar was also recently approved.
FDA Accepts ANI’s Refiled Cortophin Gel
ANI Pharmaceuticals has announced that the refiled sNDA for its Cortrophin Gel has been accepted by the FDA with a target action date of 29 October 2021. The company said that it was continuing to strengthen its rare disease business leadership team and overall organization to drive the Cortrophin Gel launch preparation.
ANI Prepares For Cortrophin Launch
US-based ANI Pharmaceuticals is looking to strengthen its leadership team and strategize a commercial approach for the launch of Cortrophin Gel, as it anticipates FDA approval by 29 October 2021. ANI reported a 2.4% increase in its generics business.