News

The FDA announced that it was withdrawing a draft guidance document, “Statistical Approaches to Evaluate Analytical Similarity,” after consideration of public comments.

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.

Guidelines recommend that disease activity should be assessed every 1 to 3 months in patients with high or moderate disease activity, and every 6 to 12 months in those with low disease activity or remission, but implementation of these principles has not been well evaluated in the United States.

During the fourth congress of the European Academy of Neurology, held in Lisbon, Portugal, from June 16 to 19, researchers presented on the roles of both existing and investigational anti-CD20 drugs in treating neurological diseases.

Anti–tumor necrosis factor (TNF) agents, widely used in rheumatology and gastroenterology, carry some safety risks. While the risk of infection or malignancy are common concerns, neurological complications, while rare, are also possible.

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.

A new study, published in Alimentary Pharmacology and Therapeutics, sought to test antigenic comparability between the reference infliximab and the biosimilar.

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).

During the fourth congress of the European Academy of Neurology, held in Lisbon, Portugal, from June 16 to 19, researchers reported on CinnaGen’s biosimilar interferon beta 1A drug, CinnoVex, in treating multiple sclerosis (MS).

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.

Ever since biosimilars arrived in the United States in 2015 with the launch of Sandoz’s Zarxio, a biosimilar of Amgen’s Neupogen, reference product manufacturers and biosimilar manufacturers have locked horns on pricing, patents and access policies—and the competition remains fierce. Now the industry is preparing for the next wave of biosimilars, which will launch from 2020 to 2030. At least 19 branded biologics, which grossed more than $40 billion worldwide in 2017, have around 80 biosimilars from 39 manufacturers under development in the United States and European Union.

Researchers from Spain, where biosimilar use is encouraged as a way to save on costs and expand access to biologic therapies, recently reported on a multicenter prospective observational study in patients with inflammatory bowel disease (IBD) who switched from reference infliximab to a biosimilar, CT-P13 (Inflectra, Remsima).

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.

This week, the American College of Rheumatology (ACR) released a new position statement on the importance of pharmacovigilance and the critical need to continue monitoring new drugs after they reach the market.

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.

In light of the publication of HHS' blueprint to reduce drug prices, the FDA has announced the issuance of 2 final guidance documents to provide greater clarity on medical product communications.

If European League Against Rheumatism guidelines are followed, when a patient with rheumatoid arthritis (RA) does not reach remission or a state of low disease activity after 6 months of treatment, then the patient’s treatment should be modified regardless of the drug therapy being used (biologic or small molecule).

The FDA has released a final guidance document intended to help industry members develop bioanalytical methods and validations that are required by the FDA to ensure the quality of an assay and the reliability of the data it generates.

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.

Crohn disease (CD) can involve physical, psychological, and social impairments that negatively impact patients’ quality of life, and high levels of anxiety and depression have been observed in patients with CD.

The American Society of Clinical Oncology’s (ASCO) annual meeting, held June 1-5, 2018, in Chicago, Illinois, featured results of numerous studies on biosimilars in anticancer and supportive care. Here are 5 key takeaways from the meeting.

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).

The FDA has approved Genentech’s innovator rituximab (Rituxan) for the treatment of adults with moderate to severe pemphigus vulgaris (PV). This expanded indication makes the drug the first biologic approved for the treatment of PV, a rare autoimmune disease that affects the skin and mucous membranes with progressive blistering.

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).