FDA accepts Samsung Bioepis’ BLA for SB8 bevacizumab biosimilar candidate

19 November 2019 - Samsung Bioepis today announced that the U.S. FDA has accepted for review the company’s biologics license ...

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Biosimilars make progress in the Canadian market, but stakeholders see more work ahead

18 November 2019 - While much attention over the past few weeks has been on the US biosimilars market, with its ...

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FDA approves Pfizer's biosimilar, Abrilada (adalimumab-afzb) for multiple inflammatory conditions

18 November 2019 - Pfizer today announced the United States FDA has approved Abrilada (adalimumab-afzb), as a biosimilar to Humira ...

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Statement from Sarah Yim, acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product

15 November 2019 - Biological products play an increasingly central role in modern medicine, offering treatments for many serious illnesses.  ...

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Valeo Pharma announces filing of a new drug submission for low molecular weight heparin in Canada

14 November 2019 - Valeo Pharma announced today that the new drug submission filed for a low molecular weight heparin ...

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Biosimilar rituximab and insulin glargine on the PBS and other PBS Listing changes - information for health professionals and patients

14 November 2019 - Biosimilar brands of rituximab (Riximyo) and insulin glargine (Semglee) have listed on the PBS on 1 October ...

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Teva and Celltrion announce the availability of Truxima (rituximab-abbs) injection, the first biosimilar to Rituxan (rituximab) in the United States

7 November 2019 - Truxima available week of November 11. ...

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Is the FDA doing enough to bring biosimilars to market?

4 November 2019 - As the number of biosimilar approvals continues to rise in the US, the number of biosimilar ...

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Sandoz receives US FDA approval for long-acting oncology supportive care biosimilar Ziextenzo (pegfilgrastim-bmez)

5 November 2019 - Ziextenzo is indicated to decrease the incidence of febrile neutropenia, one of the most serious side effects ...

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Adalimumab and the challenges for biosimilars

23 October 2019 - Biologic drugs are expensive therapeutic agents and represent a large and growing segment of pharmaceutical spending. ...

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Bill to create CMS star ratings program for biosimilars introduced in House

16 October 2019 - The bipartisan bill would require HHS to evaluate Medicare Advantage (MA) plans based on whether biosimilars are ...

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Biosimilars in the UK: where are we now and where does the NHS want to go?

9 October 2019 - The UK health service has well over a decade’s experience of dealing with biosimilars, but the ...

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Pfenex receives U.S. FDA approval for PF708 to treat osteoporosis

7 October 2019 - Comparative human factors study report expected to be submitted to FDA as early as the second half ...

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With Brexit looming, what does the future hold for UK biosimilars?

26 September 2019 - If and when the United Kingdom leaves the European Union, the Medicines and Healthcare Products Regulatory Agency ...

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Paper by European regulators foresees "continuing reduction in clinical data requirements" for biosimilars

24 September 2019 - This month, Elena Wolff-Holz, chair of the EMA’s Biosimilar Medicinal Products Working Party, together with co-authors from ...

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