Regulatory

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The FDA recently released a draft guidance document that provided an overview of the content and format of information sponsors should include in the “Indications and Usage” section of a drug label for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

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

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.

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.

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.

The Center for Biosimilars® recaps the top 5 articles for the week of June 4, 2018.

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.

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.