Business

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This week, the FDA released a draft guidance document titled “Formal Meetings Between the FDA and Sponsors or Applicants of [Biosimilar User Fee Act] BsUFA Products.”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.

Vizient, a healthcare performance improvement company, recently voiced its concerns to the Office of the United States Trade Representative about proposed tariffs on Chinese products.

This week, the European Commission proposed a “recalibration” of Supplementary Protection Certificates (SPCs) to boost investment in the development and manufacture of biosimilars and generics.

Biosimilar developer Celltrion has resubmitted its Biologics License Application (BLA) for a proposed rituximab biosimilar, CT-P10, to the FDA for regulatory consideration. The company received a Complete Response Letter for the drug in April 2018, after having received an earlier warning letter from the agency that raised concerns about the company’s manufacturing processes.

Drug maker Lupin announced last week that its marketing authorization application for a proposed etanercept biosimilar, YLB113, was accepted by the European Medicines Agency.

EvaluatePharma recently released its take on the current state of the market for orphan drugs in its Orphan Drug Report for 2018.

In the latest move by Anthem Inc., the company announced earlier this week that it plans to acquire Aspire Health, the nation’s largest non-hospice advanced care provider.

The Center for Biosimilars® recaps the top 5 articles for the week of May 21, 2018.

Novartis has announced that Sandoz, a subsidiary division of the company, has received the European Commission’s (EC) authorization for its infliximab biosimilar, to be sold as Zessly in the European Union.

As the United States lags behind Europe and other highly regulated areas in terms of biosimilar approval and uptake, research presented during the International Society for Pharmacoeconomics and Outcomes Research 23rd Annual International Meeting in Baltimore, Maryland, points to slow market entry and small price discounts of approved biosimilar products as key factors that are holding up cost savings in the US market.

The European Commission (EC) has announced that it is seeking comments on recently proposed clarifications for how the organization will handle duplicate marketing authorizations for biologics.

Given reliance on industry fees to pay for the review of medicines, as well as the pharmaceutical industry’s potential inability to sustain the level of fees required to review all new medicines without cooperation with the European Medicines Agency (EMA), the United Kingdom could have to reduce the number of drug marketing authorizations it grants each year, or raise the funds elsewhere.

This comment period is important for biosimilar stakeholders because the Trump administration's plan has addressed specific efforts being made by the FDA and HHS to improve biosimilar development, approval, education, and access.

Data from new CMS dashboards reveal that many of the drugs that have seen the highest annual growth in spending per beneficiary over the 2012 to 2016 period are products that either currently face or will soon face biosimilar or follow-on biologic competition.