The US FDA issues a complete response letter for the biologics license application for insulin aspart

7 January 2022 - The U.S. FDA has issued a complete response letter for the biologics license application for insulin ...

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JAMP and Alvotech announce Canadian approval of Simlandi, a high concentration biosimilar to Humira, providing access to previously unavailable versions in Canada

10 January 2021 - Health Canada rules that 40 mg/0.4 mL and 80 mg/0.8 mL presentations of Simlandi are not subject ...

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Celltrion acquires approval for its new Humira 'Yuflyma' in Canada

30 December 2021 - Celltrion announced on December 30 that it won marketing approval from Health Canada for "Yuflyma", a ...

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Coherus announces U.S. FDA approval of Yusimry (adalimumab-aqvh)

20 December 2021 - Approved for all eligible indications of the reference biological product, Humira (adalimumab). ...

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Sandoz submits biologics license application for proposed biosimilar trastuzumab to US FDA

20 December 2021 - Biologics license application is supported by analytical, pre-clinical and clinical data, proposed biosimilar trastuzumab developed by EirGenix. ...

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AVT02, Alvotech’s biosimilar to high concentration formulation of adalimumab (Humira) approved for use in European Union

15 December 2021 - Alvotech received approval for AVT02 (100 mg/mL), the company’s high concentration biosimilar to Humira (adalimumab), from the ...

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Henlius' fourth biologic bevacizumab biosimilar approved by National Medical Products Administration

3 December 2021 - Shanghai Henlius Biotech announced that bevacizumab biosimilar, developed and manufactured by Henlius independently, has been approved by ...

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Biosimilar follitropin alfa on the PBS - information for health care professionals and patients

7 December 2021 - A biosimilar brand of follitropin alfa (Ovaleap) was listed on the PBS on 1 December 2021.  ...

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TOT Biopharm announces NMPA granted marketing approval for Pusintin (TAB008, bevacizumab) in China

1 December 2021 - TOT Biopharm announced its self-developed Pusintin (TAB008, bevacizumab) has been officially granted approval by the National ...

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Biosimilar industry vets critique Biden's drug pricing reforms

29 November 2021 - Specialty tiers for biosimilars and reforms that address the proliferation of poor quality patents would help ...

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The BBB’s threat to biosimilar drug development

23 November 2021 - In 2019, longtime pharmaceutical industry critic, Peter Bach, took to the Wall Street Journal to declare that ...

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PHARMAC widens access to adalimumab through transition to biosimilar

17 November 2021 - Pharmac’s chief medical officer Dr David Hughes has today announced the decision to fund a biosimilar adalimumab ...

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Viatris and Biocon Biologics announce launch of interchangeable Semglee (insulin glargine-yfgn) injection and insulin glargine (insulin glargine-yfgn) injection

16 November 2021 - Branded and unbranded versions of the first-ever interchangeable biosimilar in the U.S. provide more affordable options for ...

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FDA touts success and challenges in biosimilar development

10 November 2021 - A top official from the US FDA offered a mixed assessment of the agency’s biosimilars program, noting ...

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Patient access to affordable cancer treatment increases with the launch of new biosimilar in Canada

9 November 2021 - Apobiologix today launched its first oncology therapeutic treatment Bambevi (bevacizumab), which is used in combination with ...

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