Biosimilar Development solution center

1. Don't Miss These 2025–2026 EMA IDMP Compliance Deadlines For Product Management Services 5/22/2025

   The EMA's Product Management Services will serve as a comprehensive database for consistent identification of medicines internationally. One deadline is quickly approaching on May 31. Are you ready?

2. First AMT Program OK'd Under New FDA Designation — Here's What To Know 5/21/2025

   The FDA's new Advanced Manufacturing Technology program has its first recipient, a development expected to reveal the specific ways the program benefits drug innovators.

3. Formulation Is Key For Y-mAbs' Self-Assembling Antibody 5/16/2025

   The radiotherapy company's novel SADA construct uses self-assembling tetramers to deliver isotopes directly to cancer cells for a highly targeted, less toxic treatment.

4. Nanomedicine Modalities Find Path To Clinic Through Analytics 5/16/2025

   Lipid nanoparticles have revolutionized drug delivery, ushering in a new era of nanomedicine. Discover how advanced analytical tools are accelerating next-generation LNP therapeutics.

5. Using AI To Predict Multispecific Formulation Patterns 5/16/2025

   This emerging class brings substantial formulation challenges beyond those of traditional mAbs. Here’s a comprehensive look at the issues and some solutions.

6. ADCs: The Next Phase Of Innovation 4/24/2025

   Explore the pivotal advancements in ADCs that focus on high-DAR, multispecific designs, and novel payloads, while addressing challenges in manufacturability, scalability, regulatory acceptance, and commercial viability.

7. Indian Biosimilar Companies Are Poised To Succeed In The Global Market 3/31/2025

   For Indian biosimilar developers looking to capitalize on the upcoming patent cliff, it is vital to play to your strengths and identify strategies for breaking into competitive regulatory markets.

8. Replicate Bioscience And Cytiva Collaborate To Deliver srRNA-LNP Vaccines 3/24/2025

   Discover how self-replicating RNA (srRNA) can revolutionize vaccine development with sustained protein expression, lower doses, and fewer side effects to advance next-gen RNA therapeutics.

9. A 5-Step Guide To Achieving Your Biosimilar Milestones On Time 3/24/2025

   As the biologic patent cliff looms, biosimilar developers must strategically plot their approach to development and manufacturing to secure a corner of their market and reach their target patients.

10. Thunderstruck By Antibody-Drug Conjugates 3/18/2025

    Antibody-drug conjugates are transforming cancer treatment by targeting tumors directly to reduce side effects. Discover how they affect neighboring cells, which can enhance treatment efficacy and eliminate tumor cell populations.