EuropaBio Publishes New Paper on Biosimilars

EuropaBio published a new Guide and a new Position Paper on Biosimilars in Europe. With these two documents, EuropaBio continues its contribution to the policy debate on key issues regarding biosimilars among European and national regulators, policy makers, physicians, other healthcare providers and patients.

Read the paper here.

Latest News

February 2024 Newsletter

ASBM Joins ICAN, other Patient Advocacy Organizations to Oppose Government Use of “March In Rights” In February, ASBM joined 33 other patient advocacy organizations led by the International Cancer Advocacy Network (ICAN) in a letter to U.S. Congressional leadership, urging them to oppose the use of “march-in rights” to break pharmaceutical patents for drugs developed with […]

ASBM Releases Fact Sheet on Emerging Challenges to Interchangeable Biosimilars Policy

On January 31st, ASBM released a fact sheet describing a variety of proposed policy changes at the state and federal level which would weaken the interchangeable biosimilar standard, or circumvent the patient protections it provides. These include new bills and regulations at the federal level, as well as state legislation and proposals which threaten to […]

EMA Seeks Public Comment on Re-evaluating the Need for Clinical Safety and Efficacy Data in Biosimilar Development

On January 25, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) released a document entitled “Concept paper for the development of a Reflection Paper on a tailored clinical approach in Biosimilar development”. The document expresses the EMA’s intent to streamline biosimilar development by re-evaluating the role of clinical safety and efficacy data; it also […]