Biosimilars

The FDA breakthrough decision removes clinical efficacy studies from the biosimilar pathway in suitable cases, underscoring a smarter, evidence-based regulatory approach.

FDA Grants First Ever Waiver of Clinical Efficacy Studies for Monoclonal Antibody Biosimilar

Biologics CDMO is calling. Read more about the biopharma market outlook from Marty and Nigel.

Biologics CDMO Market – Mabion Approach to Establishing Cooperation

Many lifesaving biopharmaceuticals are suffering from a slump in venture funding. Novel recombinant protein based therapeutics, but also biosimilars are needed to fill the gaps in unmet patient needs. At Mabion we understand how to advance promising biosimilars and novel biotherapeutics to the clinic and from there to patients. Unfortunately, many promising biopharmaceutical innovations spanning novel recombinant protein therapeutics to biosimilars are being held back in the current, limiting funding climate, depriving patients from access to advanced therapies. Yet the urgency to close gaps in unmet patient care has never been greater. That is why we are launching the “Unlocking the Future of Therapeutics” competition a unique opportunity to support and accelerate biologics development and scale up for an oncology-targeted therapeutic. We are offering €500,000 credit in development services to support an exceptional therapeutic project. This can be a novel therapeutic, but might also be a biosimilar drug which expands patients access to lifesaving care. We have partnered with respected academic experts focused on cancer research to select the most promising candidate.

Mabion Launches €500,000 Services Contest to Support Next-Gen Oncology Breakthroughs

Yesintek, a ustekinumab biosimilar, indicated for the plaque psoriasis treatment has received approval from both the EMA and FDA.

Biocon’s Yesintek receives EMA and FDA approval as the next ustekinumab biosimilar

Denosumab biosimilar for osteoporosis treatment.

First denosumab biosimilar approved by FDA

EMA considers dropping efficacy studies for certain biosimilars