• Biosimilars and interchangeable biosimilars have had a positive impact on public health.• Use FDA’s Purple Book Database of Licensed Biological Products to find out if your medication has an approved biosimilar. • Visit FDA's Biosimilars page to access educational materials on biosimi...
Ustekinumab-ttwe, a biosimilar to ustekinumab (Stelara) is expected launch in the US in February 2025. The FDA has approved ustekinumab (Stelara) biosimilar ustekinumab-ttwe (Pyzchiva) for all of the same indications as the reference medication, according to a news release.1 The drug has ...
“Eylea is a frequently used medication that has been FDA-approved since 2012 and has a long track record of safety and efficacy; the availability of Eylea biosimilars provide broader options for treatment for retina specialists and their patients,” he said. Sharon Fekrat, MD, a retinal surge...
the medication’s retail price is expensive. The availability of an interchangeable biosimilarmay increase market competitionand potentially lower the cost of treatment. Although the price of Bkemv has not been released, historical biosimilar
• Use FDA’s Purple Book Database of Licensed Biological Products to find out if your medication has an approved biosimilar. • VisitFDA's Biosimilars pageto access educational materials on biosimilars. UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety ...
Purple Book (database of FDA-licensed (approved) biological products, including biosimilar and interchangeable products) 紫皮书(FDA许可(批准)的生物制品数据库) 2020.3.23 FDA将生物制品从橙皮书中移除,并为其单独成立了紫皮书板块,这一板块作为较新的版块,收录了细胞、血液、基...
The US Food and Drug Administration (FDA) has approved the biosimilar tocilizumab-bavi (Tofidence), Biogen, the drug's manufacturer,announced today. It is the firsttocilizumabbiosimilar approved by the FDA. The reference product, Actemra (Genentech), was first approved by the agency in 2010. ...
The FDA has approved Dong-A ST’s ustekinumab-srlf (Imuldosa), a biosimilar to Stelara, for the treatment of patients withautoimmunediseases such as plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis, the company announced in a release.1 ...
approved 42 biosimilar products, including four interchangeable biosimilars, and has gained valuable experience about labeling considerations for biosimilar and interchangeable biosimilar products. This guidance considers that experience and includes recommendations on label...
Rituximab-abbs (Truxima, Celltrion) is the fifteenth biosimilar approved by the FDA and the sixth biosimilar approved in 2018 thus far.