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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.

Pearce IP’s Naomi Pearce speaks about the key IP strategies to enable the launch of biosimilars around the world, with a particular focus on Australia.  Offering practical tips to success for biosimilar companies, this 14 minute PiPCast touches on:

biosimilar FTO/c...

Korea Biomedical Review reported that Prestige Biopharma has voluntarily withdrawn its EMA application for the HD201 (Tuznue®, biosimilar trastuzumab).  Prestige received a negative opinion from the CHMP in May 2022, with the CHMP taking the view that the manufacturing proc...

STADA and Xbrane Biopharma announced that the CHMP provided a positive opinion for Ximluci® (biosimilar ranibizumab).  If approved, ranibizumab will be the sixth biosimilar approval for STADA, following adalimumab, bevacizumab, epoetin zeta, pegfilgrastim and teriparatide.<...

Apotex filed an IPR against Regeneron, seeking revocation of Regeneron’s method of treatment (MOT) patent US 11,253,572, relating to the sequential administration of 2mg doses of aflibercept (Eylea®) on the grounds of anticipation and obviousness.

Merck announced that Health Canada has granted approval for KEYTRUDA® (pembrolizumab), for the adjuvant treatment of adult and paediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection.

Lupin announced that Health Canada has approved Rymti® (biosimilar etanercept) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondylarthritis (including ankylosing spondylitis and non-radiographic axial spondylarthritis...

Significant biosimilar activities this week include:

25 Aug 22 | JP | Lupin and I’rom sign licence for denosumab in Japan

Lupin announced that it has entered into an exclusive licensing agreement with I’rom Group for biosimilar denosumab in Japan.  Under the a...

Novartis announced that it will invest USD300 million in the creation of a fully integrated, dedicated facility for early development of biotherapeutics.  The investment will be used to strengthen Novartis’ existing campuses in Basel and Schaftenau, and to create a dedicate...