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Top biosimilar news of the Apr 2025
INSIGHTS+

Key Biosimilars Events of April 2025  

Shots:       Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency        Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients        Henlius Collaborates with Sandoz for the Commercialization of HLX13. Our team at PharmaShots…
May 6, 2025

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Krystal Biotech
News

Krystal Biotech’s Vyjuvek (Beremagene Geperpavec-svdt) Receives the EC’s Approval for Dystrophic Epidermolysis Bullosa (DEB)

Shots:The EC has approved Vyjuvek to treat wounds in DEB pts with COL7A1 mutations from birth in all 30 EEA states, with first EU launch set in Germany by mid-2025; MAA under PMDA’s review with decision anticipated in H2'25Approval was based on comprehensive clinical dataset, incl. P-I/II (GEM-1) & P-III (GEM-3) trial data, showing…
April 29, 2025

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CuraTeQ
News

CuraTeQ Biologics Receives CHMP’s Positive Opinion for Dazublys (Biosimilar, Herceptin) 

Shots: CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, reported EMA’s CHMP has granted a positive opinion to Dazublys (150 mg powder for concentrate for solution for infusion), its trastuzumab biosimilar, to treat HER2-positive metastatic and early breast cancers. Pending expected EC approval in July, it will be available across the EU member states The opinion…
April 26, 2025

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Purpose Pharma
News

Purpose Pharma’s Attrogy Receives the CHMP’s Positive Opinion for the Treatment of Hereditary Transthyretin-mediated Amyloidosis  

Shots: The CHMP has recommended Attrogy (diflunisal) to treat hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult pts. with stage 1 or stage 2 polyneuropathy The EC will make decision within 67 days, and if approved, Attrogy will be authorized in all EU & EEA countries Iceland, Lichtenstein and Norway Diflunisal has received EU ODD for…
April 25, 2025

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Gedeon Richter
News

Gedeon Richter Receives CHMP’s Positive Opinion for Junod and Yaxwer (Biosimilars, Prolia and Xgeva) 

Shots: The CHMP has recommended marketing authorization for Junod and Yaxwer, biosimilars of Amgen’s Xgeva & Prolia (denosumab) Denosumab is approved to treat postmenopausal osteoporosis, prevent bone complications from cancer metastases, and treat unresectable giant cell tumors of bone Junod & Yaxwer are mAbs (IgG2) that block RANKL, preventing osteoclast activation  Ref: Gedeon Richter | Image: Gedeon Richter…
April 25, 2025

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PTC Therapeutics
News

PTC Therapeutics’ Sephience Receives the CHMP’s Positive Opinion for the Treatment of Phenylketonuria (PKU) 

Shots: The CHMP has issued a positive opinion recommending marketing authorization for Sephience (sepiapterin) to treat PKU in patients of all ages and disease severities, expected the EC approval within two mos., with the decision applying across the EU including Iceland, Norway, and Liechtenstein Sepiapterin's NDA is under FDA review (PDUFA: July 29, 2025), and…
April 25, 2025

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