“US Biosimilars Market, Dosage, Price and Clinical Pipeline Outlook 2025” Report Highlights:
US Biosimilar Market Current Scenario
US Biosimilars Clinical Pipeline by Company, Indication and Phase: 28 Biosimilars
Marketed Biosimilars Clinical Insight by Company and Indication: 9 Biosimilars
Biosimilars Market Opportunity: US$ 5 Billion
FDA Rules and Regulations For Biosimilars Development and Market
Approved and Marketed Biosimilars: Clinical, Price and Dosage
“US Biosimilars Market, Dosage, Price and Clinical Pipeline Outlook 2025” report gives comprehensive insight on clinical and non-clinical issues involved in the development of biosimilars market in US. Report highlights the ongoing market trends and initiatives undertaken by various stake holders to advance the approval and commercialization of biosimilars in the US pharmaceutical market.
Biosimilars have started gaining attention worldwide as they are cheaper but equally effective than their original product. Biosimilars cost lesser than biologics as they take less time to develop and go through only four stages of testing – analytical, non-clinical, clinical pharmacology and clinical studies. Biosimilars are not similar or same as generic drugs due to difference in their physiochemical properties.
Globally they are at different stages of progression with respect to adoption of biosimilars in main stream pharmaceutical market. Although European market is the most mature market in comparison to US market but it is catching up to speed. Total of 19 biosimilars have been approved by FDA since 2014, but only 8 biosimilars and 2 follow-on-biologics have been able to make it to the market as of 2019. The most recent approved biosimilar is Trazimera of Pfizer (March 11, 2019).
Most successful biosimilar in the US market has been Sandoz’s Zarxio. It captured more market than Inflectra. Biosimilars market has a bright future. The market has the potential to grow faster if some of the issues like andndash; interchangeability status, extrapolation, shortening exclusivity period etc. are solved. In addition, market competition needs to be promoted.
Currently, US biosimilars market is at the interim state. With most of the biologic products going off patent by 2025 and increasing rate of patients suffering from chronic diseases. The biosimilars market has a huge opportunity to spread it swings in the US drug market. With few reforms and education to the stakeholders this goal is achievable. The US biosimilar market will continue to evolve and grow exponentially but with small degree of uncertainty. The regulatory authorities need to form a more concrete framework to keep these grey areas of the biosimilar market in check. This, accompanied with education of physicians/patients to speed market uptake, new development and commercial paradigms can provide the proper platform for developing new commercially successful biosimilars.