EMA authorizations: CRO generics suspended and Herceptin biosimilar refused

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The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has suspended the marketing authorizations of several generics medicines tested by Synchron Research Services on 20 May 2022. The committee also refused the marketing authorization for BioPharma’s Herceptin biosimilar, Tuznue, on 19 May 2022.

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Synchron Research Services data concerns
EMA reported finding data integrity issues related to tests for approximately 100 generic products that were carried out at the contract research organization’s (CRO) facility located in Ahmedabad, India. Specifically, EMA found that no adequate bioequivalence data on the products was available from other sources, raising concerns about Synchron Research Services quality management system and the reliability of data from that site. Bioequivalence studies are key for generics as they show that a generic medicine releases the same amount of active substance in the body as the reference medicine.

It is reported that, to lift the suspension, companies relying on data from Synchron Research Services must provide alternative data demonstrating bioequivalence. Although there are some exemptions (for which data from other sources are available), the majority of medicines being tested by Synchron Research Services will not be granted authorization in the EU.

EMA has warned that some of the products may be of critical importance to patients and therefore Member States can postpone the suspension in critical situations.

Companies with affected generic drugs include J&J, Sandoz, Viatris, Teva, Jubilant, Accord Healthcare and many more.

Prestige BioPharma’s Herceptin biosimilar
Prestige BioPharma has stated that on 19 May 2022 it received a negative opinion on the marketing authorization for Tuznue, a medicine intended for the treatment of certain forms of breast cancer and gastric (stomach) cancer, from EMA’s CHMP. This has occurred due to product ‘drift’ which surrounds changes in the manufacturing process of Tuznue during the phase III study of the biosimilar. However, the company has argued that some of these changes were made in response to changes in the manufacturing of the originator, Herceptin. Such product or clinical drift has been previously reported by researchers at Sandoz [1, 2]. Prestige BioPharma can apply for re-examination by EMA within 15 days of receiving the opinion.

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1. GaBI Online - Generics and Biosimilars Initiative. Endpoints to assess interchangeability for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jun 17]. Available from: www.gabionline.net/reports/Endpoints-to-assess-interchangeability-for-biosimilars
2. Lamanna WC, Holzmann J, Cohen HP, et al. Maintaining consistent quality and clinical performance of biopharmaceuticals. Expert Opin Biol Ther. 2018:18(4):369-79.

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