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On 12 June 2025, Celltrion, Amgen and Pfizer each received FDA approval of an additional indication for their rituximab biosimilars (Truxima®, Riabni® and Ruxience®, respectively), for treatment of moderate to severe pemphigus vulgaris in adult patients.

With the new...

On 12 June 2025, the US FDA announced that it has approved MSD’s Keytruda® (pembrolizumab) for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumours express PD-L1 as determined by an FDA-approved test.  Keytruda® is approved as ...

On 11 June 2025, Sweden-based Xbrane Biopharma and OneSource Specialty Pharma, an Indian-based CDMO, announced that they have entered a partnership for the commercial manufacture of Xbrane’s biosimilar portfolio.

Xbrane’s biosimilars include Ximluci®, biosimilar to G...

On 10 June 2025, Outlook Therapeutics announced that the Scottish Medicines Consortium has accepted Lytenava™ (bevacizumab gamma) for use within NHS Scotland for the treatment of wet AMD.

Earlier this month, Outlook Therapeutics announced that it had launched Lytenav...

On 9 June 2025, the Federal Court of Australia ordered that three Janssen Biotech innovation patents be revoked (AU2024100006, AU2024100007 and AU2024100016).  The Court’s revocation orders, made before the scheduled end of the trial, bring to a conclusion the patent infrin...

On 9 June 2025, Samsung Bioepis announced that it has entered into a partnership agreement with NIPRO Corporation in Japan for multiple biosimilars, including SB17, Samsung Bioepis’ biosimilar to Janssen’s Stelara® (ustekinumab).

Under the terms of the agreement, Sam...

On 9 June 2025, the US Patent Trial and Appeal Board issued a written decision invalidating all claims of Johns Hopkins University’s US Patent No. 11,591,393 on the basis of anticipation and obviousness.  US Patent No. 11,591,393 is directed to treating patients with micros...

On 9 June 2025, Celltrion announced that its Qoyvolma® (CT-P43), biosimilar to J&J/Janssen’s Stelara® (ustekinumab) has received marketing approval from the European Commission (EC).  Qoyvolma® is Celltrion’s second European ustekinumab biosimilar, following Steqeyma®, ...

On 5 June 2025, Formycon announced that Brazil’s ANVISA has granted marketing authorisation for Ranivisio® (FYB201), biosimilar to Genentech’s Lucentis® (ranibizumab).

Formycon expects that Ranivisio® will be launched in Brazil in Q4 2025 by its commercialisation par...