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On 01 May 2024, Johnson & Johnson announced that it submitted applications to the European Medicines Agency (EMA) to expand the Marketing Authorisation for Tremfya® (guselkumab) to include the treatment of adult patients with moderately to severely active ulcerative col...

On 1 May 2024, MSD announced that the final analysis of the Phase 3 KEYNOTE-811 clinical trial (sponsored by MSD) demonstrated that Keytruda® (pembrolizumab), in combination with trastuzumab and chemotherapy, provided gastric cancer patients with a statistically significant...

On 01 May 2024, Boehringer Ingelheim announced that the FDA approved its high-concentration, citrate-free formulation of Cyltezo® (biosimilar to Abbvie’s Humira® (adalimumab)), for multiple chronic inflammatory diseases.
BI now has approvals for the high (100 mg...

On 30 April 2024, Alvotech announced a strategic partnership with Quallent Pharmaceuticals Health, under which a high-concentration interchangeable biosimilar to Humira® manufactured by Alvotech will be distributed under Quallent’s private-label.  This partnership aligns wi...

The Korean Biomedical Review has reported that Samil Pharmaceutical will launch Samsung Bioepis’ aflibercept in Korean market from 1 May 2024.  Samil and Samsung Bioepis entered into a B2B commercialisation deal for biosimilar aflibercept in February 2024, following their a...

On 26 April 2024, Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes of the applications for reimbursement considered at its March 2024 meeting.
The following biosimilars have been recommended for listing on the Pharmaceutical Benef...

On 29 April 2024, Intas subsidiary Accord BioPharma announced that the FDA has approved Hercessi™, biosimilar to Roche’s Herceptin® (trastuzumab), for the treatment of HER2-overexpressing breast and gastric / gastroesophageal junction adenocarcinoma.  This is the first US b...

On 29 April 2024, each of Amgen and Sandoz announced that they resolved the US patent litigation regarding Sandoz’s denosumab biosimilars enabling Sandoz to launch Jubbonti® and Wyost® from 31 May 2025, or earlier in certain (undisclosed) circumstances.
This concludes...

A paper published in the Journal of the American Academy of Dermatology on 27 April 2024 reported that, in a Phase 3 clinical trial sponsored by Samsung Bioepis, SB17 (ustekinumab) was biosimilar to Janssen’s Stelara® (in terms of efficacy, safety, pharmacokinetics, and imm...