News

This week, British Columbia began the process of transitioning patients with inflammatory bowel disease (IBD) to biosimilars.

Genentech has reached a memorandum of understanding with JHL Biotech in its civil lawsuit related to the theft of Genentech’s trade secrets.

The Center for Biosimilars® recaps the top stories for the week of September 2, 2019.

More than 20 groups, representing patients, employers, and others, are asking HHS to end cost-sharing for Medicare Part B patients when a provider administers a biosimilar rather than a reference biologic.

China-based drug maker TOT Biopharm is developing TAB008 as a biosimilar of the reference bevacizumab, Avastin. TOT has recently indicated that it is in the midst of a phase 3 clinical trial of the biosimilar, and last month, results of a phase 1 study of the biosimilar were published in Frontiers in Pharmacology.

Amitabh Chandra, PhD, Ethel Zimmerman Wiener professor of public policy and director of health policy research at the Harvard Kennedy School of Government, says that while price regulation is not impossible, “It’s very, very hard to do. Given that it’s hard to do, do we need to do it?”

The pharmaceutical industry hit bottom in public opinion, ranking last in Gallup’s list of 25 industries, according to a new annual poll.

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.

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.

Health Canada recently updated its fact sheet on biosimilars, including new or clarified information about key topics including interchangeability and switching.

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.

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, 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.

Recently, researchers reported on 7-year interim results from the STRIVE registry and said that the results show that most children are able to tolerate adalimumab plus methotrexate well.

One recent paper analyzed data from 3 studies on down-titration of etanercept in patients with rheumatoid arthritis (RA) and concluded that patients who have achieved disease control according to a stringent definition have a greater likelihood of remaining in remission after reducing their dose or withdrawing etanercept.

There is increasing evidence to suggest that therapeutic drug monitoring (TDM) will allow for more tailored and rational use of biologics in psoriasis.

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.

Results of a phase 3 trial of IBI303, a proposed adalimumab biosimilar referencing Humira, showed that it is therapeutically equivalent in terms of efficacy, safety, and immunogenicity to the originator product, according to a study published in the first issue of The Lancet Rheumatology.

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

Treating macular edema associated with central retinal vein occlusion (CRVO) with aflibercept was noninferior to ranibizumab treatment at 100 weeks, while the results for bevacizumab versus ranibizumab were inconclusive.

Drug maker Henlius Biotech is recruiting patients for a single-center, open-label, dose-escalation phase 1 clinical trial that will evaluate the safety and tolerability of combination therapy with a biosimilar bevacizumab and an anti–programmed cell death protein 1 (PD-1) antibody in patients with advanced solid tumors.

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.

Editorial board member Brian Lehman, MBA, MHA, RPh, examines current progress and challenges that biosimilars face in the US context, and argues that stakeholders have the opportunity to be part of the solution to high drug prices by supporting biosimilars.

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.

A new paper published this month may help to allay some concerns that US providers may have about using FDA-approved biosimilar rituximab.

In a filing with the US Securities and Exchange Commission this month, Silicon Valley-based biotech company Revance Therapeutics said that it has entered into an amendment to a Collaboration and License Agreement with Mylan; the amendment extends the period of time Mylan has to decide whether to continue to develop and commercialize a biosimilar of Allergan’s onabotulinumtoxinA (Botox).

Women are more likely than men not to take their diabetes medication as prescribed in an effort to control prescription drug costs, as are adults under age 65, according to a report published this month by the Centers for Disease Control and Prevention (CDC).

A Japanese postmarketing surveillance study of biosimilar infliximab CT-P13 (Inflectra, Remsima) concludes that the biosimilar and its reference, Remicade, are comparable in terms of efficacy and adverse drug reactions in patients with inflammatory bowel disease (IBD) and that the biosimilar is a cost-efficient option that is interchangeable with the reference in real-world practice.

Amgen announced yesterday that it will acquire apremilast (Otezla) from Celgene. The small-molecule drug, which inhibits phosphodiesterase 4, specific for cyclic adenosine monophosphate, is an orally administered therapy for patients with psoriatic arthritis and patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.