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Formycon AG and Klinge Biopharma GmbH announced that they have applied to the European Medicines Agency (EMA) for marketing authorisation in the EU for FYB203, biosimilar to Regeneron’s Eylea® (aflibercept).

Only a few days before on 24 November 2023, Celltrion annou...

Sanofi and Regeneron have announced they plan to file a supplemental biologics licence application (sBLA) with the FDA for Dupixent® (dupilumab) to treat chronic obstructive pulmonary disease (COPD) by the end of 2023.  This application will be based on two phase III clinic...

Outlook Therapeutics announced that it had a ‘Type A’ meeting with the FDA in October 2023 to discuss the Complete Response Letter (CRL) it received in August 2023 regarding its Biologics License Application (BLA) for ONS-5010, an ophthalmic formulation of bevacizumab, mark...

Celltrion revealed in a corporate filing with the Repository of Korea’s Corporate Filings (DART) that it has applied for marketing authorisation in the EU for its CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept) on 23 November 2023.  The application is based on the po...

Express Pharma reported that Enzene Biosciences has launched its biosimilar ranibizumab in India (biosimilar to Genentech’s Lucentis®) for the treatment of neovascular age-related macular degeneration (AMD).  This is Enzene’s seventh Indian biosimilar.

On 7 September...

Biocon Biologics filed an Inter Partes Review (IPR) petition against Janssen’s US patent no. 10,961,307 relating to Stelara® (ustekinumab).  Biocon Biologics is challenging all 34 claims of the patent, relating to methods of treating ulcerative colitis with ustekinumab.

Chugai Pharmaceutical announced the Japanese launch of Phesgo®, a subcutaneous combination of pertuzumab and trastuzumab (Genentech’s Perjeta® and Herceptin® respectively) to treat HER2-positive breast cancer and advanced or recurrent HER2-positive colorectal cancer that ha...

A Phase III study funded by Celltrion compared the efficacy and safety of its ustekinumab biosimilar CT-P43 to Janssen’s Stelara® (ustekinumab).  The study concluded that CT-P43 was equivalent in efficacy in treating patients with moderate to severe plaque psoriasis, and ha...

Sandoz has launched its high concentration formulation (100mg/ml) of Hyrimoz® in Europe, biosimilar to AbbVie’s Humira® (adalimumab).  This citrate-free high concentration formulation is indicated for all conditions for which Humira® is supplied.

Hyrimoz® was granted...