Regulatory - Page 2

The Center for Biosimilars® interviewed Anurag S. Rathore, PhD, whose team of investigators evaluated why applications for biosimilar approvals do not succeed. Large companies as well as small find the approval process challenging, but there is a learning curve that may be followed by more consistent approvals, he explains.
Ted Mathias and Stacie Ropka, PhD, intellectual property law partners with Axinn Veltrop and Harkrider LLP, met with The Center for Biosimilars® to discuss how insulins will be regulated under the Biologics Price Competition and Innovation Act (BPCIA) versus the Hatch-Waxman Act, as well as the new challenges follow-on manufacturers will face.
 
With insulin originator product patents expiring, drug companies are seeking to extend exclusivities via patents on injectors and other delivery products.
Investigators found that process complexities have created numerous difficulties for biosimilar developers in regulatory filings, but they anticipate that the success rate will improve with experience and improved guidance.

 
Now is the time for the FDA to lead again in revising the biosimilar development guidance by eliminating all animal toxicology studies, and replacing them with larger-species pharmacokinetic (PK) studies, allowing the conduct of human PK studies using novel clinical protocols to combine the PK/pharmacodynamic/immunogenicity testing in a single study, and, where possible, avoid these studies if an in-silico approach can provide the confidence of pharmacologic similarity.
The European Commission has granted market authorization to Sanofi for its insulin aspart biosimilar, making it the first approved biosimilar to NovoRapid for the region.
As the coronavirus disease 2019 pandemic continues to hinder the forward momentum for biosimilar approvals, FDA has shown that biosimilars are still a priority for the agency.
 A new scorecard system developed by IQVIA rates the health and sustainability of biosimilars markets across Europe.
Based on clinical studies on dosing, efficacy, and pharmacokinetics, European authorities have recommended Celltrion's subcutaneous infliximab biosimilar (Remsima SC) for 5 new indications.
New prediction methodology for calculating biosimilar application fees will help the FDA cover its costs and respond quickly to changes in demand, officials said at a public meeting.

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