Samantha DiGrande

The product did not earn approval for all indications of the reference Herceptin; it has been approved only for the treatment of HER2-positive gastric cancers, and not for the treatment of HER2-positive breast cancer.

The researchers concluded that rituximab should be considered as a preferred biologic treatment for rheumatoid arthritis (RA) therapy, though treatment of RA with any biologic medication improved quality of life significantly.

This week, JHL Biotech announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has granted the company positive scientific advice to begin a phase 3 clinical trial of its proposed trastuzumab biosimilar, JHL1188.

Although the policy change was intended to cut out-of-pocket drug costs for patients, a number of organizations, including the American College of Rheumatology (ACR), have argued that step therapy can be harmful to patients with chronic conditions. On Wednesday, ACR met with HHS Secretary Alex Azar to discuss their concerns.

As biosimilar competition nears for Roche and its subsidiary, Genentech, a new WARN notice in the state of California disclosed that Genentech is set to lay off 223 employees from a local plant beginning August 31, 2018.

Clinical director of the Irish health technology assessment (HTA) body National Centre for Pharmacoeconomics (NCP), Michael Barry, MB, FRCPI, PhD, recently said in an interview with Irish media that the lack of uptake of biosimilars in Ireland is “an issue that should be tackled,” and he proposed approaches to do just that.

CVS Caremark will allow clients to exclude any drug launched at a price greater than $100,000 per quality-adjusted life year from their plans.

This month, AbbVie filed suit against biosimilar developer Sandoz over its proposed adalimumab (Humira) biosimilar. The suit was filed in the District of New Jersey and alleges infringement under the Biologics Price Competition and Innovation Act.

Combination treatment is typically more effective than treatment with methotrexate alone, but some patients may experience adverse events with methotrexate that make monotherapy desirable.

This week, Samsung, the parent company of Samsung BioLogics and biosimilar development company Samsung Bioepis, announced plans to invest $22 billion across business lines, including biopharmaceuticals.

Celltrion’s Korean plant has received its second Form 483 from the FDA in less than a year, only months after having received a warning letter for the same facility.

Express Scripts framed its formulary as a response to pharma: “Despite promises to limit price increases, drug makers are trying to game the market by delaying generic competition, blocking access to safe and effective biosimilars, and coyly deferring—not cancelling—list price increases,” it said.

The Institute for Clinical and Economic Review (ICER) explains that, compared with anti–tumor necrosis factor (anti-TNF) drugs, both guselkumab and risankizumab offered a superior benefit based on currently available data.

Stada, a biopharmaceutical company based in Germany, recently announced that it is increasing its presence in the biosimilar sphere by becoming the majority shareholder in Bioceuticals, a venture capital-funded organization created by Stada to carry out its biosimilar programs.

China-based Clover Biopharmaceuticals recently announced that the first patient was dosed in a phase 1 trial of SCB-808, a potential etanercept (Enbrel) biosimilar.

The International Generic and Biosimilar Medicines Association (IGBA) recently sent a letter to HHS Secretary Alex Azar applauding the administration’s ongoing efforts to lower drug prices—as well as the FDA’s prioritization of improving the efficiency of biosimilar and interchangeable product development—and asking for a key change to the biosimilar approval process.

Vizient, a healthcare performance improvement company, recently released its Drug Price Forecast Highlights biannual report that provides an estimate of the change in the cost of medicines for 2019.

The Association for Accessible Medicines (AAM) has released the 10th edition of its annual Generic Drug Access and Savings Report that provides an outline of the savings generated by generics and biosimilars in the past year.

Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, recently announced that it has initiated a phase 1 clinical trial for BAT1806, a proposed tocilizumab (Actemra) biosimilar.

This month, the Maine legislature authorized a bill titled “An Act to Require Drug Manufacturers to Comply with Federal Law,” or 2017 ME S 432, which seeks to combat the misuse of Risk Evaluation and Mitigation Strategy (REMS) programs within the state.

This week, a federal appeals court declined to hear a petition to rehear a challenge by the Association for Accessible Medicines to a Maryland drug pricing law.

A new trastuzumab (Herceptin) biosimilar has launched in India. Dr Reddy’s Laboratories, the developer of the biosimilar, indicated that the drug will be sold under the name Hervycta, and that it has been approved in India to treat HER2-postive early breast cancer, metastatic breast cancer, and metastatic gastric cancer.

In order to gather stakeholder input on the initiatives explained in the Biosimilar Action Plan unveiled by FDA Commissioner Scott Gottlieb, MD, last week, the FDA has announced that it will hold a public hearing on the plan on September 4, 2018.

Yesterday, Congressman John Sarbanes, D-Maryland, introduced the Biosimilars Competition Act of 2018 in the United States House of Representatives. The bill would require biologic and biosimilar drug manufacturers to report any agreements they enter into that may keep lower-cost drugs from reaching consumers.

Last week, drug manufacturer Merck announced that it will be taking part in several strategies to establish “responsible pricing” going forward, joining the ranks of some of the latest companies taking similar actions, including Novartis and Pfizer.

Xbrane Biopharma and STADA have announced that they have entered into a collaboration agreement for the development of a ranibizumab biosimilar, referencing Lucentis, which will prospectively be sold as Xlucane, in the US, European, and other markets.

After the release of the FDA’s Biosimilar Action Plan this week, many industry stakeholders have spoken out on the actions being taken by the FDA to further competition and increase biosimilar uptake.

In its comments, the American College of Rheumatology (ACR) stressed that safe and effective treatments should be accessible to all patients at the lowest cost possible, and this mindset should be the fundamental basis for any drug-pricing policy.

During a speech given today in Washington, DC, FDA Commissioner Scott Gottlieb, MD, announced the release of the long-awaited Biosimilar Action Plan.

“This is a crucial moment for the growth of biosimilars in the United States, and we are encouraged that HHS is committed to pursuing policies that reward innovation and support provider and patient access and choice,” said Juliana M. Reed, president of the Biosimilars Forum.