Regulatory

Biosimilar developer Sandoz announced today that the European Commission has granted a marketing authorization for Hyrimoz, an adalimumab biosimilar, for all of the indications for which the reference adalimumab, Humira, is approved.

The Center for Biosimilars® recaps the top 5 articles for the week of July 23, 2018.

“It’s one thing for us to get the biosimilar approved and go through all of that,” said Juliana M. Reed, corporate affairs global biosimilars lead for Pfizer. “That was the early conversation of the market developing. Now the market needs to be accessible.”

On the whole, the FDA’s plan, says Robert Cerwinski, JD, is “net good news for the biosimilar developers,” and should provide “tailwinds” for the industry by giving greater clarity, streamlining processes, and reducing the time and expense that biosimilar developers will need to bring their products to the marketplace.

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.

The United Kingdom’s Members of Parliament voted 305 to 301 to approve an amendment to the Trade Bill that will require the nation’s negotiators to try to secure UK involvement in the European Medicines Agency (EMA) after Brexit.

The FDA has approved Pfizer's filgrastim-aafi, a filgrastim biosimilar to Amgen's Neupogen. The product, the second filgrastim biosimilar approved in the United States, will be sold under the brand name Nivestym.

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.

Catch up on the week’s top policy, clinical, business, regulatory, legal, and international news from the world of biosimilars.

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

The FDA has finalized its guidance on labeling of biosimilar products, and FDA Commissioner Scott Gottlieb, MD, called the finalized guidance "one of a suite of deliverables" that will be unveiled as part of the Biosimilars Action Plan.

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.

The Center for Biosimilars® recaps the top 5 articles for the week of July 9, 2018.

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.”

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.

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

The FDA continues to update its list of off-patent, off-exclusivity drugs without approved generic competitors to meet the organization's broader goals defined under the Drug Competition Action Plan.

Health Canada, Canada’s governmental health agency, announced that there is now an option for all biological and pharmaceutical new drug submissions to request aligned regulatory reviews between Health Canada and health technology assessment (HTA) organizations.

This month saw a variety of developments in the world of biosimilar drugs for the treatment of rheumatic diseases.

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

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.

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.

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.

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

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.