- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Robert Cerwinski: Reference Product Sponsors and Biosimilar Development
Robert Cerwinski, JD, partner at Goodwin, discusses the challenges that reference product sponsors encounter when they also seek to develop biosimilars.
Transcript:
A very interesting question. What we see in the biosimilar space that we don’t see as often in the generic drug space are brand companies really aggressively pursuing biosimilars of competitor products. We do see companies like Amgen play both sides of the fence. We also see that, at least with respect to questions like “what are the requirements of the patent dance? Is it mandatory, is it not?”, Amgen has really had to be very careful in the line in takes.
As a biosimilar defendant, where the economic imperative is to get to market as fast as possible, whereas on the branded side every day of delay, every month of delay represents an economic advantage. We do see currently that companies that are playing both sides of the fence have to be very, very careful. Since a biosimilar can be quite profitable though, and since biosimilars present one way for branded companies to compete against their other branded competitors, I don’t think Amgen will be alone. I think we will continue to see branded companies really vigorously pursue biosimilar opportunities of competitor products.
BioRationality: Biosimilar Associations and Stakeholders Representing Biosimilars
January 20th 2025Sarfaraz K. Niazi, PhD, dives into the role that biosimilar associations and organizations play in promoting biosimilars as well as how their stakeholder demographic and main objectives differ from one another.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Study Confirms CT-P42 Therapeutic Equivalence to Reference Aflibercept in DME
January 6th 2025The phase 3 trial showed biosimilar CT-P42 (Celltrion) is therapeutically equivalent to reference aflibercept in improving visual acuity in patients with diabetic macular edema (DME), with comparable efficacy, safety, pharmacokinetics, and immunogenicity at 24 weeks, with more long-term data expected.
