Regulatory

When Can Biologic Patent Disputes Go Before the ITC?

June 25th 2019

By Allison Inserro

Under which situations might the International Trade Commission (ITC) be the right choice for biosimilar patent disputes instead of federal district court? A panel discussed these questions at the ACI 10th Summit on Biosimilars on Monday in New York City.

Deputy Director Talks About Implementing Biosimilar Policy Within the FDA

June 24th 2019

By Allison Inserro

With a variety of policy ideas circulating around Washington, DC, in regards to stimulating biosimilar competition and lowering drug prices, the role of the FDA is to provide technical assistance to those legislative staffers and others looking for information, a key FDA official told a packed audience at the ACI 10th Summit on Biosimilars on Monday in New York City.

EMA to Review Henlius' Trastuzumab Biosimilar, HLX02

June 24th 2019

By The Center for Biosimilars Staff

China-based drug maker Henlius has announced that the European Medicines Agency (EMA) has accepted for review the company’s marketing authorization application for a trastuzumab biosimilar, HLX02, referencing Herceptin.

Alexion to Receive Priority Review for Ravulizumab as Eculizumab Biosimilars Close In

June 22nd 2019

By The Center for Biosimilars Staff

Drug maker Alexion, developer of the rare disease drug eculizumab (Soliris), announced Friday that the FDA has accepted for priority review its long-acting C5 complement inhibitor, ravulizumab (Ultomiris), which offers less frequent administration than eculizumab.

When Analytical Characterization of a Biosimilar Reveals Shifts in Quality Attributes of a Reference Product

June 21st 2019

By Kelly Davio

The attributes for the N-glycan profile, FcγRIIIa binding activity, and relative antibody-dependent cell-mediated cytotoxicity (ADCC) activity for the reference trastuzumab resulted in reduced ADCC and FcγRIIIa binding activities.

Eye on Pharma: Biocon Receives EU GMP Certification

June 19th 2019

By The Center for Biosimilars Staff

Biocon’s biologics facilities in Bengaluru, India, have received an EU certification of good manufacturing practice (GMP) after a March 2019 inspection, said the drug maker last week in a notice to the National Stock Exchange of India.

The Top 5 Biosimilars Articles for the Week of June 10

June 14th 2019

The Center for Biosimilars® recaps the top stories for the week of June 10, 2019.

FDA Approves Amgen's Trastuzumab Biosimilar, Kanjinti

June 13th 2019

By The Center for Biosimilars Staff

Kanjinti was approved for the treatment of HER2-positive breast cancer and gastric cancer.

Brand-Name Rituximab Will Get FDA Priority Review for a New Pediatric Indication

June 13th 2019

By The Center for Biosimilars Staff

Drug maker Genentech, developer of the brand-name rituximab, Rituxan, has announced that the FDA has accepted a supplemental Biologics License Application for the drug’s first proposed pediatric indication: 2 rare forms of vasculitis.

Should the FDA Disclose New Filings for Drugs, Biologics, and Biosimilars?

June 11th 2019

By Kelly Davio

This month, a research letter appearing in JAMA Internal Medicine raises the questions of whether regulatory filings for new products are already made publicly available despite the FDA’s stance of treating these applications as confidential and whether there is room for increased transparency from the agency.