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China publishes draft guideline for adalimumab copy biologicals Guidelines | Posted 24/04/2020

On 1 April 2020, China’s Center for Drug Evaluation (CDE) published draft guidance on clinical trials for the approval of adalimumab copy biologicals.

Merck launches trastuzumab biosimilar in the US Biosimilars/News | Posted 24/04/2020

US pharma giant Merck (known as MSD outside the US and Canada) and Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced in on 15 April 2020 that they had launched their trastu...

Assessment of biosimilarity for monoclonal antibodies Biosimilars/Research | Posted 24/04/2020

How therapeutic monoclonal antibody biosimilars are assessed for biosimilarity, was discussed by authors from the National Institute of Health Sciences and the Yokohama University of Pharmacy in Ja...

Alberta delays deadline for forced medication switch by six months Policies & Legislation | Posted 24/04/2020

The Canadian province of Alberta has delayed its introduction of a switching policy to biosimilars for patients using biologicals for six months.

FDA releases new information on interchangeable biologicals Biosimilars/General | Posted 24/04/2020

The US Food and Drug Administration (FDA) has released new information on its website, clarifying the difference between biosimilars and interchangeable biologicals and says it will make more treat...

Market for copy biologicals in ASEAN and China expected to grow Reports | Posted 24/04/2020

The Association of Southeast Asian Nations (ASEAN) and China market for copy biologicals was valued at US687.6 million in 2017 and is expected to reach US$5.5 billion by 2025 with a compound annual...

EC approval for rituximab biosimilar Ruxience Biosimilars/News | Posted 24/04/2020

On 2 April 2020, pharma giant Pfizer announced that its rituximab biosimilar, Ruxience (PF‑05280586), had received European Commission (EC) approval.

Science, outreach, development: US Generics Drugs Office reaches new highs in 2019 Generics/General | Posted 24/04/2020

The US Food and Drug Administration (FDA) Office of Generic Drugs 2019 Annual report gave updates on the number of generics approvals in 2019. These remained high at 1,014 [1-3]. The report also di...