Samantha DiGrande

A Pfizer manufacturing site for injectable drugs, Hospira Healthcare in Tamil Nadu, India, has received a 32-page Form 483 from the FDA.

This week, JHL Biotech announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has granted ithe company a positive Scientific Advice to begin a phase 3 clinical trial of its potential rituximab biosimilar, JHL1101.

Vermont and Connecticut have recently signed laws providing a pathway for and regulations around the substitution of interchangeable biosimilars for the reference biologic product at the pharmacy level.

Earlier this month, US Senators Chuck Grassley, R-Iowa, and Amy Klobuchar, D-Minnesota, sent a letter to Federal Trade Commission (FTC) Chairman Joseph Simons urging the FTC to “examine whether makers of biologic medicines are using strategies like ‘pay-for-delay’ to hinder or delay biosimilars from entering the market.”

Prestige BioPharma and Alvogen have recently announced that they have entered into an exclusive partnership for the commercialization of Prestige BioPharma’s trastuzumab biosimilarin Central and Eastern Europe.

Amgen recently announced top-line results from a phase 3 clinical trial that sought to evaluate the safety and efficacy of its proposed infliximab biosimilar, ABP 710, compared with the reference product (Remicade) in patients with moderate-to-severe rheumatoid arthritis (RA).

The FDA recently released a draft guidance document that provided an overview of the content and format of information sponsors should include in the “Indications and Usage” section of a drug label for drugs and biologics.

Last week, the FDA issued a 32-page Form 483 to Mylan after a 5-week inspection of its manufacturing plant in Morgantown, West Virginia. The FDA cited 13 inspection observations, including failure to follow proper quality control protocols, lack of adequate cleaning of utensils and equipment, and ineffective laboratory controls and sampling, among others.

The FDA recently released a draft guidance document entitled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.” The guidance is meant to address various industry inquiries around the implementation of the Biosimilar User Fee Amendments II (BsUFA II).

Last week, the European Specialist Nurses Organisations (ESNO) released a document aimed at assisting nurses in the management of switching a patient from a reference biologic to a biosimilar.

A recent study looked to evaluate the association between infliximab trough levels, response to treatment, and quality of life in a cohort of Brazilian irritable bowel disease (IBD) patients.

The presence or absence of insurance coverage for trastuzumab treatment was the strongest predictor of trastuzumab therapy use in Chinese patients.

In a presentation during the American Conference Institute’s Summit on Biosimilars, held June 25-27 in New York, New York, Laura Sim, JD, senior counsel at Amgen, and Vishal Gupta, JD, partner at Steptoe & Johnson LLP, discussed various naming and labeling considerations that stakeholders need to consider for biosimilars.

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.

Isaac Ashkenazi, partner at Paul Hastings LLP; Gregory Morris, PhD, partner and leader of life sciences litigation at Honigman Miller Schwartz and Cohn LLP; and John Molenda, PhD, partner and co-chair of Healthcare & Life Sciences practice at Steptoe & Johnson LLP, discussed current “hot button” litigation issues in the biosimilar sphere during the American Conference Institute’s Summit on Biosimilars, held June 25-27.

At the American Conference Institute (ACI)’s Summit on Biosimilars Conference, held June 25-27 in New York, New York, panelists Crystal Kuntz, vice president of healthcare policy and research at Biotechnology Innovation Organization, and David Korn, vice president of intellectual property and law at Pharmaceutical Research and Manufacturers of America, provided an overview of recent policy and legislative updates in regard to biosimilars.

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.

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).

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.

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.

During the European League Against Rheumatism’s Annual European Congress of Rheumatology, held from June 13-16 in Amsterdam, Netherlands, researchers presented findings on adalimumab biosimilars, referencing Humira.

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.

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.

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).

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.

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.