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Here are the top 5 biosimilars articles for the week of June 25.

Although no biosimilar has earned an interchangeable designation by the FDA to date, the distinction could garner more biosimilar uptake. In a presentation during the American Conference Institute’s Summit on Biosimilars, held June 25-27 in New York, New York, various stakeholders discussed how interchangeability is the future of the space.

Lupin pharmaceuticals has entered into an agreement with Nichi-Iko for the distribution, promotion, and sale of its proposed biosimilar etanercept, YLB113, in Japan.

Catch up on the week’s top rheumatology, gastroenterology, neurology, clinical practice, advocacy, regulatory, policy, and business news from the world of biosimilars.

Reuters is reporting that pharmaceutical companies may be shifting the amount of taxes they owe in the United States by holding their valuable drug patents overseas.

Senator Orrin Hatch, R-Utah, has filed an amendment to the Creating and Restoring Equal Access to Equivalent Samples Act, which was advanced to the Senate by the Judiciary Committee on June 14, 2018.

The American Medical Association (AMA) has announced that, after assessing the proposed $69 billion merger between pharmacy benefit manager CVS Health and insurer Aetna, the organization is calling for regulators to block the transaction.

The United States Patent Trial and Appeal Board (PTAB) has denied biosimilar developer Samsung Bioepis’ request for inter partes review (IPR) of a patent that Genentech holds covering reference trastuzumab (Herceptin).

Korean drug maker Celltrion has announced that it has resubmitted its Biologics License Application for CT-P6, a trastuzumab molecule referencing Herceptin. Separately, Celltrion announced new data for its proposed subcutaneous formulation of its flagship biosimilar, CT-P13, an infliximab biosimilar referencing Remicade, in patients with rheumatoid arthritis.

The survey found that, for the United States specifically, in the informed public segment, there was a 20% drop in the general trust in healthcare, giving the United States market the second biggest drop following Colombia. Globally, trust declined in 16 of 28 markets studied, noting an average 4% decline in trust in healthcare globally.

In a webcast hosted by the Alliance for Health Policy that took place earlier this week, Robert Langreth, senior health reporter for Bloomberg News, Dora Hughes, MD, MPH, senior policy advisor at Sidley Austin, LLP, and Sameer Awsare, MD, associate executive director of the Permanente Medical Group at Kaiser Permanente, came together to discuss the best ways to bring down the steadily increasing drug prices in the United States. The panel was moderated by Mary Ella Payne, RN, MSPH, president of the Alliance for Health Policy.

The Center for Biosimilars® recaps the top 5 articles for the week of June 11, 2018.

The Senate Judiciary Committee today voted 16 to 5 to report the Creating and Restoring Equal Access to Equivalent Samples Act (CREATES Act) to the Senate floor.

HHS Secretary Alex Azar today testified before the Senate’s Committee on Health, Education, Labor, and Pensions on the Trump administration’s blueprint to lower drug prices.

“I see no reason as a healthcare provider to intentionally go back and forth needlessly, but I see no concerns that, if I do that, bad things would happen,” said Jason Schairer, MD.

Walgreen and Kroger have filed an antitrust lawsuit against Johnson & Johnson (J&J) and Janssen over Remicade.

This week, the International Generic and Biosimilar Medicines Association (IGBA) was elected as a Management Committee Member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

This week, a Delaware District court granted Boehringer Ingelheim’s (BI) motion to compel discovery in AbbVie v Boehringer Ingelheim, an ongoing litigation over adalimumab (Humira).

EvaluatePharma, a company that provides consensus forecasts of the pharmaceutical and biotechnology sphere, recently published its 11th edition of its World Preview. In this 2018 installment, the company provided an overview of what investors and other stakeholders can expect to see in the industry from 2018 to 2024.

Republic of Korea-based biosimilar developer Celltrion, maker of Inflectra, has announced that it will launch a contract development and manufacturing business to develop novel agents alongside its biosimilar pipeline.

This week, the FDA released a draft guidance document titled “Formal Meetings Between the FDA and Sponsors or Applicants of [Biosimilar User Fee Act] BsUFA Products.” The guidance offers clarification to industry members on the procedures and specifications of formal meetings with the FDA.

Celltrion presented new research that demonstrates that a formulation of its infliximab biosimilar intended for subcutaneous administration is comparable to the intravenously administered option. The phase 1 study compared the subcutaneous formulation—which can be self-administered—with the FDA-approved intravenous formulation in patients with active Crohn disease (CD).

The FDA has approved Mylan and Biocon’s pegfilgrastim biosimilar, pegfilgrastim-jmdb. The product, the first biosimilar pegfilgrastim approved in the United States, will be sold under the brand name Fulphila.

On June 1, drug maker Apotex announced that its Apobiologix division has received approval from Health Canada for its pegfilgrastim biosimilar, Lapelga. Lapelga is the first pegfilgrastim biosimilar to be approved in a highly regulated territory.

Mylan and its partner Biocon have received a Complete Response Letter from the FDA in regard to their application for a follow-on insulin glargine referencing Lantus.

Amgen has announced that the FDA has issued a Complete Response Letter for its biosimilar trastuzumab candidate, ABP 980.

The Center for Biosimilars® recaps the top 5 articles for the week of May 28, 2018.

On Friday morning in Chicago, Illinois, The Atlantic hosted a series of panels, moderated by Steve Clemons, on the role biosimilars in cancer care. Opening the morning’s proceedings were Gary Lyman, MD, MPH, co-director of the Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, and Chadi Nabhan, MD, MBA, FACP, CMO of Cardinal Health Specialty Solutions.

Two biosimilar developers today announced that they have received positive opinions for products from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

FDA Commissioner Scott Gottlieb, MD, on Thursday announced new draft guidance documents aimed at limiting the potential for drug makers to abuse Risk Evaluation and Mitigation Strategy (REMS) requirements. The announcement comes on the heels of President Donald Trump’s drug pricing plan, which called on the agency to issue guidance on how manufacturers use REMS programs to delay competition from follow-on products.