article thumbnail

EMA proposes streamlined approach for biosimilar development

European Pharmaceutical Review

The European Medicines Agency (EMA) has published a new draft reflection paper , which discusses reducing the quantity of clinical data needed for development and regulatory approval of biosimilars. This is part of the agencys work to improve the development and assessment of biosimilar medicines, while maintaining EU safety standards.

article thumbnail

CuraTeQ Biologics’ Trastuzumab biosimilar Receives Positive Opinion in Europe

Big Molecule Watch

This week, CuraTeQ Biologics (a wholly owned step-down subsidiary of Aurobindo Pharma Limited) announced that its trastuzumab biosimilar, DAZUBLYS, has received a positive opinion from the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP).

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

R&D and tech innovation boosting biopharmaceutical market to 2030

European Pharmaceutical Review

These include innovations in biotechnology, the expansion of biosimilar medicines and increasing investment in research and development. The post R&D and tech innovation boosting biopharmaceutical market to 2030 appeared first on European Pharmaceutical Review. Key players in the global biopharmaceutical market include AbbVie Inc.,

article thumbnail

Yugal Sikri outlines 3 key trends defining India’s pharma growth in 2025

Express Pharma

The sector is targeting a remarkable $130 billion by 2030 and a visionary $450 billion by 2047. The potential extension of the PLI scheme to biosimilars could further catalyze growth in this rapidly expanding segment. India’s pharmaceutical industry, a global leader in generics, is poised for exponential growth.

article thumbnail

CPHI & PMEC India expo to be held from Nov 26-28, 2024

Express Pharma

India’s pharma industry is on an impressive growth trajectory, expected to reach $65 billion by 2024 and to double to $130 billion by 2030. Renowned as a comprehensive, one-stop destination for innovative, cost-effective solutions, the expo will be showcasing the pharmaceutical industry’s modernisation, innovation, and sustainability.

article thumbnail

Dr Reddy’s completes Phase I study of DRL_TC, a tocilizumab biosimilar candidate

Express Pharma

Dr Reddy’s Laboratories announced that its tocilizumab biosimilar candidate, DRL_TC, successfully met its primary and secondary endpoints in a Phase I study. Dr Reddy’s is developing the proposed tocilizumab biosimilar as both intravenous and subcutaneous formulations.” billion patients by 2030.”

article thumbnail

Basics of Biosimilars

Integra X Files

Drugs vs. Biologics: What’s the Difference If you ask a layperson about biosimilars, you are likely to hear comparisons to generic drugs, and that would not be completely wrong. Biosimilar products are not drugs and they are not generic, in the sense that they’re not identical to the reference product.