The Center for Biosimilars Staff


Eye on Pharma: Celltrion Seeks to Expand Portfolio After IPO

July 17, 2017

Celltrion Healthcare, the marketing subsidiary of Celltrion Inc, has secured approximately $886.3 million—well over a previously projected $713 million—in its July initial public offering of 24.6 million primary shares.

No Repeal, Replacement of Medicare's IPAB Provision in Sight, Despite 2017 Reprieve

July 14, 2017

In its annual report, issued earlier this week, the Medicare program’s trustees said that Medicare will remain solvent until 2029, allowing the program to forestall triggering an Affordable Care Act provision to convene the Independent Payment Advisory Board.

Study Shows Similar Safety, Efficacy of Reference and Biosimilar Filgrastim in DLBCL

July 12, 2017

Biosimilar filgrastim is used to prevent chemotherapy-induced neutropenia and febrile neutropenia, but there exist only limited observational data concerning the use of granulocyte-colony stimulating factor treatments in patients who have non-Hodgkin’s lymphoma, including sub-types such as diffuse large B-cell lymphoma.

FDA Seeks Comments on Its Program for Enhanced Review Transparency and Communication

July 10, 2017

On June 29, the Federal Register published the FDA’s request for comments concerning its statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for original 351(k) Biologics License Applications.

Biocad Expects Marketing Authorization in India for Its Rituximab Biosimilar

July 10, 2017

Biocad has announced that, on June 20, India’s Central Drugs Standard Control Organization (CDSCO) recommended its rituximab biosimilar (Acellbia) for approval. The company expects to receive a permanent marketing authorization for the product in August, and anticipates that it will begin shipping the treatment to India by September.