News

Early-onset inflammatory bowel disease (IBD) can have a more aggressive course than later-onset disease, making prompt treatment for children with IBD especially important. Given the high cost of biologics that treat pediatric IBD—adalimumab and infliximab—biosimilars are emerging as an important cost-saving option that can prevent the premature termination of biologic therapy for financial reasons.

As more biosimilars make their way to patients in the United States and Europe, stakeholders seek reassurance on switching to these products. A newly published systematic review sought to investigate the safety and efficacy of switching between reference and biosimilar infliximab in patients with inflammatory disorders.

AbbVie has struck agreements with multiple developers over biosimilar adalimumab, forestalling US market entry until 2023. Here's when each product could potentially reach US patients.

Genentech says that the biosimilar company benefited from its proprietary information, and a hearing is scheduled for December 13, 2018.

During the Community Oncology Alliance Payer Summit, held October 29-30, 2018, The Center for Biosimilars® had the opportunity to sit down with several oncologists to discuss their opinions on and experiences with biosimilars.

In its investor call on Thursday, Coherus Biosciences revealed that it will launch its biosimilar pegfilgrastim, Udenyca, at a 33% discount to the reference Neulasta.

The Center for Biosimilars® recaps the top news for the week of November 5, 2018.

After the votes from the midterm elections were counted Tuesday and the Democrats had gained a majority in the US House of Representatives while Republicans reinvigorated their hold on the Senate, it was clear that a hot topic on voters’ minds was the high cost of drugs in the United States; however, questions remain as to what the newly elected officials will be able to accomplish to reduce prices.

The Canadian Agency for Drugs and Technologies in Health, the Canadian entity responsible for health technology assessments (HTAs), has released a new report that explores international policies related to biosimilars and the factors that facilitate their use.

Allergan’s dry-eye drug, Restasis, has been the subject of complex legal wrangling involving the transfer of patents that could next extend to the Supreme Court of the United States. Now, in a separate twist in the story of generic competition for the cyclosporine ophthalmic emulsion, generic developer Teva has sued the FDA in the United States district court for the District of Columbia over Teva’s status as the first filer of a generic version of the drug.

According to the earnings report, aflibercept sales in the United States increased 7% to $1.02 billion versus third quarter 2017 results.

Notably, Oncobiologics revealed that it is developing the bevacizumab product as an innovator therapy, and it will not use the biosimilar pathway for eventual approval.

Momenta Pharmaceuticals announced yesterday that it has reached a settlement with Humira-maker AbbVie over a proposed biosimilar adalimumab, M923.

Elaine Herrmann Blais, partner; Scott Lassman, partner; and Alexandra Valenti, associate at Goodwin, covered 3 areas of topics ranging from the Biologics Price Competition and Innovation Act litigation, updates on the Patent Trial and Appeal Board, and recent regulatory and FDA issues related to biosimilars.

At the Department of Abdominal Oncology at the National Cancer Institute of Naples in Italy, an expert pharmacist was involved in evaluating the economic impact of improving the Italian registry of high-cost drugs, particularly bevacizumab, cetuximab, panitumumab, and trastuzumab.

Republic of Korea-based Celltrion has won a court decision that declared patents on Roche’s Herceptin invalid in Japan.

Amgen filed a cross appeal in this long-running case on October 15, 2018. The appeal challenges, among other things, the district court’s previous judgement that Hospira had not infringed on another patent named in the original suit, US Patent Number 5,756,349, which covers the production of erythropoietin.

Samsung Bioepis, maker of Imraldi, has developed an autoinjector device that aims to address some of the mobility limitations that patients with rheumatoid arthritis may have in self-administering their adalimumab with a syringe.

Sandoz announced on Friday that it will no longer pursue FDA approval for its biosimilar rituximab, GP2013.

While US patients with HER2-positive cancers do not have an available subcutaneous trastuzumab option, Brazil, Canada, and the European Union have an approved product that has been shown in a phase 3 trial to be noninferior to intravenous trastuzumab.

In a recently published bipartisan report, representatives Diana DeGette, D-Colorado, and Tom Reed, R-New York, co-chairs of the Congressional Diabetes Caucus, released findings from a year-long inquiry into the sources of ever-increasing insulin prices.

The Center for Biosimilars® recaps the top news for the week of October 29, 2018.

After previous US regulatory setbacks, Coherus Biosciences has gained FDA approval for its pegfilgrastim biosimilar, Udenyca (pegfilgrastim-cbqv).

In an effort to combat competition from biosimilar adalimumab products in Europe as patents covering the reference product expired last month, AbbVie, developer of Humira, is reportedly prepared to offer a substantial discount. However, many European nations have policies that require a mandatory reduction of the reference product’s list price after biosimilar entry.

In an interview with The Center for Biosimilars®, Imron Aly, JD, partner at Schiff Hardin LLP, explained that this long-running case to invoke sovereign immunity from inter partes review (IPR) carries important lessons for innovator product sponsors and generic and biosimilar developers as they consider IPR proceedings and the patent landscape as a whole.

US voters will head to the polls next week in the midterm elections, and in the run-up to the election, the Kaiser Family Foundation has revealed that pharmaceutical companies have donated nearly $79 million to members of Congress over the past 6 election cycles.

On an earnings call earlier this week, Pfizer CEO Ian Read said that the company will be returning to “business as normal” on its drug pricing in January, after having agreed to hold off on price increases earlier this year following pressure from the Trump administration.

Given the high burden of cancer in the senior population, and given the increasingly high cost of cancer care, there is a growing interest in value-based oncology care payment models, particularly within CMS.

According to the United States Attorney's Office, Xanthe Lam, a principal scientist at the Roche Holding AG unit from 1986 until 2017, conspired with her husband and fellow former employee Allen Lam, and John Chan, another former Genentech employee, to steal trade secrets over the course of 5 years related to the biopharmaceutical dornase alfa (Pulmozyme) and some of Roche’s top-selling cancer drugs: rituximab (Rituxan), trastuzumab (Herceptin), and bevacizumab (Avastin).

Current treatment for cutaneous lupus erythematosus (CLE) commonly focuses on photoprotection, topical therapies, corticosteroids, antimalarial drugs, and immunosuppressive drugs. More recently, B-cell depleting therapies, such as rituximab, have shown promise in treating systemic lupus erythematosus, though the feasibility of treating CLE with rituximab has not been well described.