Business

Eye on Pharma: Celltrion Will Contract With Lonza to Manufacture CT-P13

September 4th 2019

By The Center for Biosimilars Staff

Celltrion announced this week that it will contract with Swiss biologics maker Lonza to manufacture biosimilar infliximab CT-P13, sold as Remsima and Inflectra, in Singapore.

National Health Service Reports Substantial Savings From Biosimilar Adalimumab

September 4th 2019

By Kelly Davio

England’s National Health Service (NHS) says that it has saved £110 million (US $134 million) by implementing its policy to use the best-value adalimumab after the brand-name Humira lost European patent protection in October 2018.

PTAB Will Review Key Patents on Brand-Name Eculizumab, Soliris

September 3rd 2019

By Kelly Davio

Last week, the Patent Trial and Appeal Board (PTAB) instituted 3 inter partes review proceedings concerning patents on Alexion’s brand-name eculizumab, Soliris, a complement inhibitor that treats rare diseases. Amgen is the petitioner in all 3 cases, which were filed in February of this year.

Mylan and Biocon Get a Second CRL for Insulin Glargine Follow-on

September 3rd 2019

By Kelly Davio

Over the weekend, drug maker Biocon disclosed that it and partner Mylan have been issued a second Complete Response Letter (CRL) for their follow-on insulin glargine product referencing Lantus.

Sandoz to Commercialize Biosimilar of MS Drug, Natalizumab

September 3rd 2019

By Kelly Davio

Sandoz, a Novartis division, announced today that it has entered into a global commercialization agreement with Poland-based Polpharma Biologics for a proposed natalizumab biosimilar referencing Biogen’s Tysabri. Natalizumab is a disease-modifying therapy used to treat relapsing-remitting multiple sclerosis (MS) as well as Crohn disease.

Dutch Experience Demonstrates Effective Benchmarking of Biosimilar Use in Health Systems

August 31st 2019

By The Center for Biosimilars Staff

As medicines become more numerous and often more expensive, healthcare professionals seek new ways to understand which treatments are most likely to yield the best outcomes at sustainable costs.

Biosimilar Business Roundup: August 2019

August 30th 2019

By Kelly Davio

In the oncology realm, August 2019’s biggest business development was the forward momentum of Amgen’s 2 newly debuted oncology biosimilars, and perhaps the biggest news in the biosimilar space from the inflammatory disease perspective also involved Amgen and its involvement in a long-running patent dispute.

The Top 5 Biosimilars Articles for the Week of August 26

August 30th 2019

The Center for Biosimilars® recaps the top stories for the week of August 26, 2019.

Parties Agree That Mylan's Pegfilgrastim Biosimilar Does Not Infringe Amgen's Patent

August 29th 2019

By Kelly Davio

Amgen, maker of the brand-name pegfilgrastim (Neulasta), and Mylan, which partnered with Biocon to develop a biosimilar (Fulphila), have entered a joint status report in the District Court for the Western District of Pennsylvania.

Eculizumab Approved in Europe for NMOSD, Another Candidate Moves Forward in the United States

August 28th 2019

By Allison Inserro

This week saw a pair of developments for patients with neuromyelitis optica spectrum disorder (NMOSD), a rare, severe, relapsing, neuroinflammatory autoimmune disease that can be fatal.