The Center for Biosimilars Staff

December 19, 2019

The promise of biosimilars is that these subsequent-entry products can reduce the cost of biologic therapy by offering lower-priced alternatives that do not compromise efficacy or safety. An additional benefit is that the presence of competition in the marketplace can also drive down costs for originator products, or at least curb price growth, though to what degree biosimilars have had such an impact on originator biologics in the US market has not been fully elucidated.

December 18, 2019

This week, the US Court of Appeals for the Federal Circuit affirmed a district court decision against Pfizer subsidiary Hospira related to an epoetin alfa biosimilar.

December 18, 2019

The pan-Canadian Pharmaceutical Alliance engaged the Canadian Agency for Drugs and Technologies in Health to lead a multiphase stakeholder consultation process to encourage biosimilar uptake.

December 17, 2019

No biosimilar adalimumab launches are currently announced for the US market prior to 2023 as a result of patent settlements struck between biosimilar developers and Humira’s maker, AbbVie, and new data show that innovative biologics currently being developed may be able to provide superior benefits versus the older adalimumab product that may make biosimilars of this therapy less appealing treatment choices.

December 16, 2019

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Pfizer’s biosimilar adalimumab referencing Humira. The product, which Pfizer proposes to market under the name Amsparity, will now be reviewed by the European Commission before it receives final marketing authorization.

December 12, 2019

Organizations are releasing patient education materials about what biosimilars are, what questions patients should ask, and other things they might want to know. The latest such example comes from Susan G. Komen, which recently released a guide to using biosimilars and biologics for breast cancer.

December 11, 2019

AffaMed Therapeutics announced this week that it has received a Clinical Trial Application (CTA) approval from Chinese regulators to conduct a phase 3 clinical trial of Samsung Bioepis’ biosimilar trastuzumab, SB3.

December 10, 2019

While biosimilars approved by regulators have been shown to have no clinically meaningful differences from their reference products, this week, during the San Antonio Breast Cancer Symposium, held in San Antonio, Texas, researchers will report reassuring data for biosimilar trastuzumab, Ogivri, showing that the combination of the biosimilar with pertuzumab is highly similar to the combination of the reference drug with pertuzumab.

December 07, 2019

Israel-based Kamada Ltd announced this week that it has entered into an agreement with Iceland-based Alvotech to commercialize 6 biosimilar products in Israel once the products gain local regulatory approval.

December 04, 2019

Generic drug maker Lannett Company announced positive results from the beginning of a clinical program for its proposed biosimilar insulin glargine referencing Lantus.