News

The Center for Biosimilars® recaps the top stories for the week of September 9, 2019.

While chances of her leaked plan to force lower drug prices in the United States getting through the Republican-controlled Senate are extremely small, House Speaker Nancy Pelosi, D-California, put biosimilars, including insulins, into the national conversation this week.

Insulin maker Novo Nordisk has announced that, in January of 2020, it will launch authorized generics of its NovoLog (insulin aspart) and NovoLog Mix (insulin aspart protamine and insulin aspart) products. Notably, the authorized generics will become available before the March 2020 transition of insulins to regulation as biologics and biosimilars rather than drugs and generics.

National and state patient, physician, and healthcare professional organizations—370 in all—are asking Congress to pass a bipartisan bill aimed at curtailing prior authorization requirements in Medicare Advantage, saying that they needlessly delay or deny access to medically necessary care.

Just last week, Sandoz indicated that it will commercialize a biosimilar of the multiple sclerosis (MS) drug natalizumab (Tysabri). This week, during the 35th meeting of the European Committee for Treatment and Research in Multiple Sclerosis, held September 11-13 in Stockholm, Sweden, researchers will present data that help contextualize natalizumab’s place in the treatment paradigm for MS.

A paper published in Pharmaceutics describes development and validation of a production process for 5 mg tablets of infliximab, using biosimilar CT-P13 (Remsima, Inflectra), for the treatment of inflammatory bowel disease.

Patient organizations for those with inflammatory bowel disease (IBD) are upset with the government of British Columbia for a plan to shift patients to biosimilars over the next 6 months.

Republic of Korea–based biosimilar developer Celltrion has announced that its trastuzumab biosimilar, CT-P6, which it markets as Herzuma, has received authorization from Health Canada.

It is already understood that a longer disease duration and delays in using disease-modifying antirheumatic drugs (DMARDs) in patients with rheumatoid arthritis (RA) is associated with worse disease control, but a new study, published just last month, has shown that the number of conventional DMARDs used before starting anti–tumor necrosis factor (anti-TNF) therapy could reduce the magnitude of a patient’s response to anti-TNFs like adalimumab.

A new report released Monday by UnitedHealth Group finds that administering specialty drugs—which are typically injected or infused—in homes or in independent physician offices instead of hospitals could save as much as $4 billion each year.

Last week, Alexion disclosed in a filing to the US Securities and Exchange Commission that the European Patent Office did not grant Alexion its request for 2 patents on its brand-name eculizumab product, Soliris, a C5 complement inhibitor that treats rare and ultrarare diseases.

For patients with rheumatoid arthritis (RA), avoiding damage to cartilage and bone in the joints is a key consideration for treatment. While anti–tumor necrosis factor (anti-TNF) therapies are used to treat RA and reduce joint destruction, the available anti-TNF agents, both originator and biosimilar, have not been directly compared with one another or with placebo in terms of their impacts on joint damage. A new study, published last week, attempted to address that gap in the literature by conducting a meta-analysis of randomized controlled trials (RCTs).

Janssen, a unit of Johnson & Johnson, announced this week that the European Commission has approved its ustekinumab (Stelara) for the treatment of moderate to severe ulcerative colitis. Also approved in the European Union to treat plaque psoriasis, psoriatic arthritis, and Crohn disease, the biologic is the first available therapy that targets the interleukin-12 and -23 pathway.

Iceland-based Alvotech and Singapore-based Prestige Biopharma have entered a contract manufacturing partnership for Prestige’s biosimilars.

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.