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BioBlast® w/e 19 August 2022: J&J Remicade decline, ALX evorpacept, FDA approves 100mg/mL Hadlima™, Formycon Ph III ustekinumab trials, Beovu® additional indication, EC approves Vegzelma™, Fresenius Kabi tocilizumab, Cipla pegfilgrastim, Merck/Orna Therapeutics collaboration

by , | Aug 22, 2022

Significant biosimilar activities this week include:

11 Aug 22 | ALX Oncology initiates Ph II trials of evorpacept in combination with cetuximab and pembrolizumab

ALX Oncology announced the initiation of Ph II trials of evorpacept (CD47 blocker) in combination with Erbitux® (cetuximab) and Keytruda® (pembrolizumab) for the treatment of refractory microsatellite stable metastatic colorectal cancer following at least two lines of systemic therapy.

16 August 22 | Merck and Orna Therapeutics enter into collaboration agreement

Merck and Orna Therapeutics announced that they have entered into a collaboration agreement to discover, develop and commercialise multiple RNA programs, including vaccines and therapeutics in the areas of infectious diseases and oncology.

16 Aug 22 | US | Formycon reports on ustekinumab biosimilar Ph III trials

Formycon has reported that its ustekinumab biosimilar candidate FYB202 showed comparable efficacy and safety to Janssen’s Stelara in a Ph III clinical trial in plaque psoriasis patients.  Formycon’s extended pharmacokinetics Ph I study has commenced.  This follows Formycon’s acquisition of 100% of the rights to FYB202 from Athos, as previously reported.

17 Aug 22 | US | Samsung and Organon announce FDA approval of high concentration adalimumab biosimilar (HADLIMA)

Samsung Bioepis and Organon announced that the FDA has approved the citrate-free, high-concentration (100mg/mL) formulation of Hadlima™ (biosimilar adalimumab).  The Hadlima 50mg/ml formulation was FDA approved in July 2019.  Hadlima is expected to be launched on or after 1 July 2023, in accordance with its settlement with AbbVie announced in April 2018.

17 Aug 22 | KR | Novartis’ Beovu® granted additional indication for diabetic macular oedema

Korea Biomedical Review reported that Korea’s Ministry of Food and Drug Safety has approved an expanded indication for Novartis’ Beovu® (brolucizumab).  The approved indications now include diabetic macular oedema.

18 Aug 22 | EU | European Commission approves Vegzelma™ (biosimilar bevacizumab)

Celltrion announced that the EC approved Vegzelma™ (biosimilar bevacizumab) for the treatment of metastatic breast cancer, non-small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer and cervical cancer.  The CHMP recommended the approval of Vegzelma in June 2022.

18 Aug 22 | Fresenius Kabi submits tocilizumab MAA to EMA

Fresenius Kabi announced that the EMA has accepted its MAA for MSB11456 (biosimilar tocilizumab).  The application includes clinical data for both subcutaneous and IV administrations.

19 Aug 22 | AU | TGA approves Cipla’s FILPEGLA® (biosimilar pegfilgrastim)

AU’s TGA approved Cipla’s FILPEGLA® (biosimilar pegfilgrastim) for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infection, as manifested by febrile neutropenia.

19 July 22 | US | J&J report a 53% decrease in Remicade® exports

Johnson & Johnson reported a 53% YoY decrease in exports of Remicade® (infliximab) from the US suggesting a very significant decline in global Remicade sales since the first approved biosimilar in 2013.

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