Biosimilars: Harmonizing the Approval Guidelines

Harmonizing lung cancer screening guidelines.

N ew guidelines on lung cancer screening narrow the scope of who should be screened for the disease, as well as define where and how people should be screened. The guidelines were a combined effort of a pulmon-ologist and director of the Center for Health Policy and Outcomes at Memorial Sloan– Kettering Cancer Center in New York, who chaired the panel. " Many organizations have established sepa...

Biosimilars: part 1: proposed regulatory criteria for FDA approval.

Biosimilars, although not identical to their originator product, are expected to become essential in reducing health care costs and improving access to lifesaving drugs. The FDA must find a way to balance rigorous testing to ensure quality, as is done for generic chemical drugs, with providing a cost-efficient way to expedite approvals of these products.

Regulatory guidelines for biosimilars in Malaysia.

The biosimilars sector continues to attract huge interest and controversy. Biosimilars are new biopharmaceuticals that are "similar" but not identical to the innovator product. Characteristics of biopharmaceuticals are closely related to the manufacturing process, which implies that the products cannot be exactly duplicated. Minuscule differences in the product's structure and manufacturing pro...

Biosimilars

An Overview of Current Regulatory Requirements for Approval of Biosimilar Insulins

Insulin analog patent expiry is likely to mean that, increasingly, copies of original biopharmaceutical products will be submitted for authorization. Experience with biosimilars in other therapeutic areas suggests that careful regulation and caution are needed. Published guidelines of regulatory authorities around the world on approval of biosimilars and, where available, insulin biosimilars we...