BioBlast® w/e 23 Sep 22: Stada/Alvotech’s adalimumab launch, AZ/Merck olaparib PRC approval, AVEO’s ficlatuzumab US fast-tracked, Sandoz’s denosumab, interchangeability in the EU, Coherus’ US ranibizumab launch, Celltrion invalidates Rituxan® patent, Formycon’s pembrolizumab, Celltrion’s bevacizumab

by , | Sep 26, 2022

Significant biosimilar activities this week include:

22 Sep 22 | CH | STADA launches Alvotech’s Hukyndra® (100mg/mL adalimumab) in Switzerland

Alvotech and STADA announced the launch of Hukyndra® (100mg/mL, citrate free biosimilar adalimumab) in Switzerland.  Alvotech reached a settlement with AbbVie in April 2022, enabling the launch of adalimumab across Europe, and STADA has since launched Hukyndra in several European countries from June 2022.  Alvotech and STADA announced an exclusive partnership in November 2019 relating to six biosimilars, including adalimumab.

22 Sep 22 | CN | China’s NMP approves Lynparza® (olaparib)/bevacizumab combination

AstraZeneca and Merck (“MSD” outside North America) announced that China’s NMP has approved Lynparza® (olaparib) as first-line maintenance treatment for adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD)-positive status.

20 Sep 22 | US | FDA grants fast track designation to ficlatuzumab

AVEO Oncology announced that the FDA has granted fast track designation to ficlatuzumab (its investigational humanized IgG1 mAb targeting hepatocyte growth factor) for the treatment of relapsed or recurrent head and neck squamous cell carcinoma.

20 Sep 22 | TW | Celltrion invalidates Roche’s Rituxan® patent

Korea Biomedical Review reported that Celltrion has successfully invalidated a Taiwanese Roche rituximab patent relating to the treatment of rheumatoid arthritis.  Celltrion reported that it will now expand its label in Taiwan to include all indications of Rituxan®.

19 Sep 22 | Sandoz publishes results of Ph I/III trials re biosimilar denosumab

Sandoz announced the results of its Ph I/III trials of its biosimilar denosumab.  Sandoz reported that the results confirm that the biosimilar matches the pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity of the reference product.

19 Sep 22 | EU | EMA confirms interchangeability of biosimilars in EU

The EMA’s Biosimilar Medicines Working Party and the Heads of Medicines Agencies Biosimilars Working Group issued a joint statement (which was endorsed by the CHMP and the Biologics Working Party), confirming that biosimilar medicines approved in the EU are interchangeable with the reference product or with an equivalent biosimilar.  Previously, interchangeability was permitted if the national regulatory agency allowed it, and EMA had not previously issued an official position on interchangeability.  EMA confirmed that substitution at the pharmacy level will remain a matter for national governments.  It is hoped that this harmonised approach will provide clarity for healthcare professionals prescribing biologics.

19 Sep 22 | US | Coherus announces US launch of Cimerli™ (ranibizumab) on 03 October 2022

Coherus Biosciences announced that it will launch Cimerli™ (interchangeable biosimilar ranibizumab) in the US on 03 October 2022.  Cimerli was approved by the FDA as interchangeable with Genentech/Roche’s Lucentis® and the EMA in August 2022.

19 Sep 22 | Formycon discloses details about FYB206/biosimilar pembrolizumab

Formycon disclosed that it is developing a biosimilar of Keytruda® (pembrolizumab), referred to as FYB206.  The project is at an advanced preclinical stage, with GMP manufacturing planned for the end of 2022.

19 Sep 22 | UK | MHRA approves Celltrion’s Vegzelma™ (biosimilar bevacizumab)

Korea Biomedical Review reported that the UK’s MHRA has approved Celltrion’s Vegzelma™ (biosimilar bevacizumab) for the same indications as Avastin®.  The EMA approved Vegzelma in August 2022.

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