Read our latest updates & insights

PTAB denied institution of Mylan’s IPR challenge to US10,857,205 (relating to Regeneron’s Eylea® aflibercept), after Regeneron filed a disclaimer with the USPTO, disclaiming all claims of the patent.   

–

On 1 March 2023, the PBS published its Summary of Changes, which included listing Celltrion’s Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), on the PBS in 40mg/0.4ml pre-filled pen and syringes.  This comes after Yuflyma® was recommended for PBS-listing by the Austr...

A new study published in Gastroenterology Research and Practice has found that British Columbia’s 2019 ‘Biosimilars Initiative’ was not associated with harmful impacts on medications and health services use.  The Initiative required IBD patients to switch from Johnson &...

Biospectrum India reported that Enzene Biosciences has launched its adalimumab (biosimilar to AbbVie’s Humira®) in India for the treatment of ankylosis spondylitis and rheumatoid arthritis.  Enzene believes that this is the first commercial launch using continuous manufactu...

Celltrion filed an application for inter-partes review (IPR) against a fourth Regeneron US patent 10,406,226 relating to a method of making a VEGF antagonist fusion protein, including the fusion protein aflibercept supplied by Regeneron as Eylea®.    

Celltrion previ...

Genentech has filed separate complaints against Biogen (in the US District Court Northern District of California) and Millennium (in the Superior Court of State of California) alleging breach of their respective licences to the Cabilly patents.  The Cabilly patents related ...

Significant biosimilar activities this week include:

22 February 2023 | EU | AbbVie sued by Dutch group over Humira® pricing 

The Financial Times has reported that the Dutch Pharmaceutical Accountability Foundation (PAF), a public interest group, is suing Abbv...

Eisai and Biogen announced that its BLA for LEQEMBI™ (in the US) (lecanemab) an investigational anti-amyloid beta (Aβ) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China.  The assessment period for L...

AbbVie announced that the EMA CHMP recommended approval of RINVOQ® (upadacitinib) for treatment of moderate to severe Chron’s disease when patients have not responded to conventional therapy or biologic.  The CHMP relied on three phase III trials, including two induction st...

Korean Biomed has reported that Celltrion has entered into a joint R&D contract with GeneMedicine, a Korean anticancer virus development company, to develop CT-P6, biosimilar to Genentech’s Herceptin® (trastuzumab), in system administration form.  Celltrion will provide...