On 3 May 2024, Indian-headquartered Lupin, in partnership with Sandoz, announced its Canadian launch of etanercept biosimilar Rymti®, biosimilar to Amgen’s Enbrel®, with a full indication set. Rymti® is supplied in a pre-filled pen and syringe and is Lupin’s fi...
We are delighted to announce that Pearce IP’s Founder and CEO, Naomi Pearce has been selected as a finalist for the 2024 IP Partner of the Year at the Lawyers Weekly Partner of the ...
On 2 May 2024, Amgen revealed that it initiated a Phase 3 study to compare the efficacy, pharmacokinetics, safety and immunogenicity of its pembrolizumab biosimilar, ABP 234, with Keytruda® in patients with advanced or metastatic non-squamous non-small cell lung cancer.
On 2 May 2024, Celltrion announced that it has won a 12 month tender to supply Remsima®, biosimilar to Janssen’s Remicade® (infliximab) and Herzuma®, biosimilar to Roche’s Herceptin® (trastuzumab), in Peru. Celltrion expects to capture 86% of Peru’s infliximab market and 5...
On 01 May 2024, Johnson & Johnson announced that it submitted applications to the European Medicines Agency (EMA) to expand the Marketing Authorisation for Tremfya® (guselkumab) to include the treatment of adult patients with moderately to severely active ulcerative col...
On 1 May 2024, MSD announced that the final analysis of the Phase 3 KEYNOTE-811 clinical trial (sponsored by MSD) demonstrated that Keytruda® (pembrolizumab), in combination with trastuzumab and chemotherapy, provided gastric cancer patients with a statistically significant...
On 01 May 2024, Boehringer Ingelheim announced that the FDA approved its high-concentration, citrate-free formulation of Cyltezo® (biosimilar to Abbvie’s Humira® (adalimumab)), for multiple chronic inflammatory diseases.
BI now has approvals for the high (100 mg...
On 30 April 2024, Alvotech announced a strategic partnership with Quallent Pharmaceuticals Health, under which a high-concentration interchangeable biosimilar to Humira® manufactured by Alvotech will be distributed under Quallent’s private-label. This partnership aligns wi...
Pearce IP publishes free e-books addressing various aspects of patent law and practice in Australia, with a focus on issues affecting pharmaceutical, biopharmaceutical and other life sciences companies.
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