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The Australian Therapeutic Goods Administration (TGA) has updated its register of prescription medicines under evaluation adding 11 new medicines which were accepted for review between February and March 2024.  Amongst others, the register shows:
In February:

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On 28 March 2024, the Korea IT Times reported the US launch of Celltrion’s pediatric 20mg Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), for the treatment of pediatric autoimmune disease. Three Yuflyma® dosage forms are now available in the US, with an 80mg dose lau...

Astellas announced that the China National Medical Products Administration (NMPA) accepted its supplemental Biologics License Application (sBLA) for enfortumab vedotin and Keytruda® (pembrolizumab) combination therapy for adult patients with previously untreated locally adv...

Merck (MSD) announced that the European Commission approved Keytruda® (pembrolizumab) in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer (NSCLC).  The ...

On 27 March 2024, Korea Biomedical Review reported that Korean biologics manufacturer Rophibio (affiliate of  healthcare company Amicogen) entered into an agreement with US biotech Avantor to supply raw materials and provide support for the development of a biosimilar to MS...

On 27 March 2024, Biocon announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) approved its liraglutide in the UK, which is the first approved biosimilar to Novo Nordisk’s Victoza® (liraglutide).  Biocon’s liraglutide, a drug-device combination (6mg/...

On 26 March 2024, MSD announced that its WINREVAIR™ (sotatercept-csrk) has been approved by the FDA for treating adults with pulmonary arterial hypertension (PAH).  FDA classified WINREVAIR™ as a breakthrough therapy due to it representing a new class of therapy which funct...

The perils of prioritising commercial strategies over patenting strategies
Pearce IP’s Founder Naomi Pearce discusses this topic on prime time radio with ABC Law Report Host Damian Carrick, in light of the recent decision of the Federal Court in Allied Pumps Pty...