News

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.

The FDA has approved Sandoz’s biosimilar adalimumab, Hyrimoz (adalimumab-adaz).

With the launch of some of the most highly anticipated products thus far in the biosimilar experience, and with the release of key new data on multiple biosimilar products, October 2018 was a memorable month for biosimilar stakeholders.

The Salt Lake Tribune is reporting that public employees in the state of Utah could be paid by their insurance plan to fill prescriptions for high-cost drugs in Mexico instead of in their local pharmacies.

In recent years, spending on specialty drugs, including spending on a proliferation of orphan drugs that treat rare diseases, has raised concerns about sustainability of the healthcare system.

A recent population-based study examined the prescribing and utilization of CT-P13 versus the reference infliximab in infliximab-naïve patients and found that discontinuation and switching were more common among patients who began therapy with the biosimilar.

A recent study presented at the Annual Scientific Meeting of the British Blood Transfusion Society, held in Brighton, United Kingdom from October 3-5, 2018, sought to determine the impact of introducing biosimilar filgrastim (sold in the United Kingdom as Zarzio) on the number of patients who were able to achieve target CD34 yield in peripheral blood stem cell mobilization (PBCM).

The arrival of biosimilar adalimumab in European markets has been cause for enthusiasm among those seeking greater patient access and lower costs for the treatment of rheumatoid arthritis (RA). However, AbbVie (maker of the reference adalimumab, Humira) has revealed that its oral Janus kinase inhibitor, upadacitinib, outperformed both placebo and adalimumab in a phase 3 study.

While real-world data, such as those derived from the NOR-SWITCH study, have been reassuring about the feasibility of switching patients with inflammatory diseases from reference infliximab (Remicade) to biosimilar CT-P13 (sold as Inflectra and Remsima), some ambiguous data in patients with inflammatory bowel disease (IBD) have raised questions among clinicians about switching in the indications of Crohn disease and ulcerative colitis.

NeuClone has announced the start of its first-in-human trial of a trastuzumab biosimilar in a phase 1 trial.