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Home / News / Pearce IP Blog

PEARCE IP BLOG

Read our latest updates & insights

Stay informed about important legal and industry news with our blogs and weekly BioBlast® updates.

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Recent BioBlast® Updates

Formycon/Klinge Partners with Actor in AU and Megalabs in LATAM for Biosimilar Aflibercept

Oct 16, 2025

On 16 October 2025, Formycon announced that Klinge Biopharma, the exclusive holder of the global commercialisation rights for Formycon’s FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), has entered exclusive licence agreements with Actor Pharmaceuticals and Uruguay-based Megalabs S.A. for the commercialisation of FYB203 in Australia and Latin America, respectively.

Regeneron to Submit Additional Manufacturer to FDA for Eylea HD® Due to Catalent FDA Action

Oct 13, 2025

On 13 October 2025, Regeneron announced that it has been notified by Catalent Indiana, LLC, which was acquired by Novo Nordisk and is the manufacturer filler included in the supplemental BLA for Regeneron’s high dose (8mg) formulation of Eylea® (aflibercept) , that Catalent received an “official action indicated” classification from the FDA on 9 October 2025.  This classification indicates that the facility is in an “unacceptable state of compliance” after an FDA inspection. 

Celltrion’s Biosimilar Aflibercept Sixth Approved in US

Oct 10, 2025

On 10 October 2025, Celltrion announced that the FDA has approved Eydenzelt® (CT-P42), biosimilar to Regeneron/Bayer’s Eylea (aflibercept 2mg), for treating nAMD, macular oedema following retinal vein occlusion, diabetic macular oedema and diabetic retinopathy. 

Sandoz’s Afqlir® First Aflibercept Biosimilar Approved in NZ

Oct 9, 2025

On 9 October 2025, New Zealand’s Medsafe approved Sandoz’s Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept 2mg), in vial and pre-filled syringe presentations, making Afqlir® the first aflibercept biosimilar approved in New Zealand.

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