Samantha DiGrande

July 16, 2018

A Pfizer manufacturing site for injectable drugs, Hospira Healthcare in Tamil Nadu, India, has received a 32-page Form 483 from the FDA.

July 15, 2018

This week, JHL Biotech announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has granted ithe company a positive Scientific Advice to begin a phase 3 clinical trial of its potential rituximab biosimilar, JHL1101.

July 14, 2018

Vermont and Connecticut have recently signed laws providing a pathway for and regulations around the substitution of interchangeable biosimilars for the reference biologic product at the pharmacy level.

July 13, 2018

Earlier this month, US Senators Chuck Grassley, R-Iowa, and Amy Klobuchar, D-Minnesota, sent a letter to Federal Trade Commission (FTC) Chairman Joseph Simons urging the FTC to “examine whether makers of biologic medicines are using strategies like ‘pay-for-delay’ to hinder or delay biosimilars from entering the market.”

July 12, 2018

Prestige BioPharma and Alvogen have recently announced that they have entered into an exclusive partnership for the commercialization of Prestige BioPharma’s trastuzumab biosimilarin Central and Eastern Europe.

July 12, 2018

Amgen recently announced top-line results from a phase 3 clinical trial that sought to evaluate the safety and efficacy of its proposed infliximab biosimilar, ABP 710, compared with the reference product (Remicade) in patients with moderate-to-severe rheumatoid arthritis (RA).

July 11, 2018

The FDA recently released a draft guidance document that provided an overview of the content and format of information sponsors should include in the “Indications and Usage” section of a drug label for drugs and biologics.

July 10, 2018

Last week, the FDA issued a 32-page Form 483 to Mylan after a 5-week inspection of its manufacturing plant in Morgantown, West Virginia. The FDA cited 13 inspection observations, including failure to follow proper quality control protocols, lack of adequate cleaning of utensils and equipment, and ineffective laboratory controls and sampling, among others.

July 09, 2018

The FDA recently released a draft guidance document entitled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.” The guidance is meant to address various industry inquiries around the implementation of the Biosimilar User Fee Amendments II (BsUFA II).

July 05, 2018

Last week, the European Specialist Nurses Organisations (ESNO) released a document aimed at assisting nurses in the management of switching a patient from a reference biologic to a biosimilar.