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On 05 March 2020, the Federal Circuit Court affirmed the District Court’s judgement of non-infringement in the Celltrion v Janssen (infliximab) matter.

On 02 March 2020, Celltrion launched Remsima SC, its subcutaneous infliximab product, in the UK. To support the launch, Celltrion held a symposium at which it showcased the product and supporting data. Celltrion has signed a framework agreement with the NHS to supply the pr...

Significant biosimilar activities this week include
24 Feb 20 | The FDA launched a searchable version of the ‘Purple Book’, containing information about FDA licensed biological products.
 24 Feb 20 | Canadian News Agency Folio drew attention to a stu...

Despite receiving CHMP approval earlier this month, Pfizer has announced it does not currently plan to launch Amsparity (adalimumab) in the EU, citing unfavourable market conditions.

On 28 February 2020, Harbour BioMed announced FDA approval of its Investigational New Drug application for HBM4003, an anti-CTLA-4 antibody and candidate for the treatment of advanced solid tumours.

Sandoz’s US President announced a focus on biosimilars and complex generics as it re-prioritises its US portfolio. As part of the re-prioritisation, Sandoz will sell much of its small molecule generics portfolio to Aurobindo Pharma.

On 24 Feb 2020, Canadian News Agency Folio drew attention to a study released by the University of Alberta revealing doctors may face legal and ethical challenges when switching patients to biosimilars. The study suggests that despite a body of evidence supporting the safet...

On 24 Feb 2020, the FDA launched a searchable version of the ‘Purple Book’, containing information about FDA licensed biological products.

Significant biosimilar activities this week include
12 Feb 20 | Wockhardt announced divestment of assets to Dr Reddy’s, under which 62 products and a manufacturing facility will be sold for $259 million. Wockhardt stated that the funds will enable it to invest i...