Read our latest updates & insights

The IPRs (inter-partes reviews) commenced by Mylan against Regeneron’s Eylea® patents 9,669,069 and 9,254,338 (instituted in December 2021) were heard by the PTAB together on 10 August 2022.  The patents relate to Regeneron’s blockbuster product Eylea® (aflibercept) and ana...

Significant biosimilar activities this week include:

27 Jul 22 | AU | Viatris (Mylan) seeks PBS listing for etanercept biosimilar

Alphapharm (Viatris’ Australian subsidiary) has its etanercept biosimilar, Nepexto®, on the agenda for the November PBAC meeting. ...

Pearce IP’s Naomi Pearce speaks about the hot topic in Australian patent law: Patent Term Extension (PTE) in Australia

Amgen announced that it has agreed to acquire ChemoCentryx, a biopharmaceutical company focused on auto-immune diseases, inflammatory disorders and cancer, for around $3.7 billion.  ChemoCentryx markets Tavneos® (avacopan), a first-in-class treatment for multi-system autoim...

In its earnings call on 4 August 2022, Coherus announced that it is developing a high concentration adalimumab formulation, which it intends to market following launch of its 50mg/ml citrate-free Yusimry™ formulation in July 2023.  Coherus also shared its plans to capture “...

Regeneron has filed a complaint against Mylan in West Virginia under the BPCIA alleging infringement of twenty-four patents relating to Eylea® (aflibercept).  This follows the FDA’s acceptance for review of Mylan’s aBLA for its aflibercept biosimilar.  Regeneron recently li...

Coherus Biosciences announced that the FDA has approved Coherus’ Cimerli™, a biosimilar to Genentech’s Lucentis® (ranibizumab).  Cimerli is the third approved US biosimilar, but is the first to be approved for all five of Lucentis’ indications and to receive the interchange...