May 14th 2024
The ISPOR report highlights the urgent need for clear guidance on when and how to conduct health technology assessments (HTAs) for biosimilars, emphasizing the challenges faced by HTA agencies and the evolving role of HTAs in evaluating biosimilar value.
ACR Says Short-Term Insurance Plans Could Hurt Patients With Rheumatic Diseases
April 27th 2018The American College of Rheumatology (ACR) told CMS in a letter this week that short-term, limited-duration insurance plans could reduce or restrict access to crucial care for people living with rheumatic diseases.
Nicholas Mitrokostas, JD, Responds to Changes to IPRs in the Biosimilars Context
April 25th 2018While all eyes were on the Supreme Court of the United States’ ruling in the much-anticipated Oil States Energy Services, LLC, v Greene’s Energy Group, LLC, the Court issued a second key ruling this week in SAS Institute v Iancu, Director, United States Patent and Trademark Office, et al—one that will also impact inter partes review (IPR) of biologic drug patents.
EFCCA Report Highlights Unequal Access to Biologics and Biosimilars for IBD
April 25th 2018The European Federation of Crohn’s and Ulcerative Colitis Associations (EFCCA), an umbrella organization that represents 34 patient associations around the world, recently released a report on healthcare inequities among nations and regions. In the report, the EFCCA identified disparities in access to biologics and biosimilars.
Landmark SCOTUS Ruling Upholds the Inter Partes Review Process
April 24th 2018The Supreme Court of the United States (SCOTUS) ruled today in the case of Oil States Energy Services, LLC, v Greene’s Energy Group, LLC, that the inter partes review process for reviewing patents does not violate the Constitution by adjudicating public rights outside of an Article III court. The Court ruled 7 to 2, with Chief Justice John Roberts and Justice Neil Gorsuch dissenting.
Panelists Grapple With Healthcare Payment Models and Patient Access
April 20th 2018In a panel during the National Policy and Advocacy Summit on Biologics and Biosimilars, held in Washington, DC, on April 17, rheumatologist Madelaine Feldman, MD; Wayne Winegarden, PhD, of the Pacific Research Institute; and rheumatologist Angus Worthing, MD, chair of the American College of Rheumatology’s Government Affairs Committee, discussed trends in healthcare payment models.
Congressman Buddy Carter is "All In" on Biosimilars
April 19th 2018At the National Policy and Advocacy Summit on Biologics and Biosimilars, held in Washington, DC, on April 17, Earl “Buddy” Carter, Republican Congressman for Georgia’s first legislative district, highlighted his work to control the price of drugs for patients.
Tahir Amin: Transparency in Drug Pricing
April 18th 2018Tahir Amin, DipLP, co-founder and director of intellectual property of Initiative for Medicines, Access, and Knowledge, a public interest team of attorneys and scientists who ensure that patents do not obstruct access to affordable medicines for patients in the United States and around the world, discusses transparency in drug pricing.
ACR Says Final Rule on EHB Benchmark Plans Could Reduce Access to Biologics
April 13th 2018This week, the American College of Rheumatology (ACR) raised concerns that CMS’ final 2019 Payment Notice Rule, which provides states with increased flexibility to determine which plan options they can select as Essential Health Benefit- (EHB) benchmark plans and select their own sets of benefits, could seriously jeopardize care for patients with inflammatory diseases.
Celltrion Asks for Summary Judgment of Non-Infringement in Inflectra Case
April 12th 2018In ongoing litigation over Celltrion and Pfizer’s infliximab biosimilar, Inflectra, a Massachusetts district court has granted Celltrion’s motion for leave to file a motion for summary judgment of non-infringement.
Pfizer Execs Underscore the Need for a Level Playing Field for Biosimilars
April 10th 2018In a press briefing today at Pfizer’s headquarters in New York, New York, Pfizer’s executives reviewed their progress with biosimilars to date and underscored the need for a level playing field if biosimilars are to compete with brand-name biologics in the United States.
Misuse of Limited Distribution Networks Prevents Biosimilar Market Entry
April 10th 2018Limited distribution networks, which are established when a drug maker contracts with either 1 or a limited number of distributors, can allow a manufacturer to efficiently manage the supply chain for a given product. However, as a recent paper argues, LDNs can have an anticompetitive impact on the marketplace.
AAM Addresses Relationships with Patient Groups in New Code of Ethics
April 10th 2018In terms of the interactions with patient organizations, the code specifies that companies should not only respect the autonomy of patient organizations and their independence, but also ensure that support for patient advocacy organizations in the form of grants or charitable contributions not be conditional on promoting a specific medicine.
New Database Tracks Pharma's Donations to Patient Advocacy Groups
April 9th 2018The database, called “Pre$cription for Power,” shows that donations to patient advocacy groups overshadowed the total amount the companies spent on federal lobbying in 2015; of the 14 companies that contributed $116 million to advocacy groups, the same companies reported only about $63 million in lobbying activities for the same time period.
FDA Releases 5-Year Financial Plan for Biosimilar User Fee Act
April 6th 2018The financial plan, which is revised each year, outlines the financial position of the Biosimilar User Fee Act program over the next 5-year authorization period, and explains how the FDA will allocate resources to build its biosimilars review program.
NHS Prepares for October 2018 Arrival of Biosimilar Adalimumab
April 4th 2018In a briefing to regional committees, the United Kingdom's National Health Service (NHS) urged commissioners to begin planning to use the best-value adalimumab option beginning in October 2018, when Amgen’s EU-authorized biosimilar, Amgevita, becomes available.
CMS Final Rule Lowers Maximum Co-Payment Amount for Biosimilars
April 3rd 2018In the rule, CMS said that it would lower the maximum co-pay amount for low-income subsidy (LIS) beneficiaries for biosimilar and interchangeable biosimilars to match the lower co-pay amount required for generic and preferred multiple-source drugs.
HSGAC Report: Drug Prices Rise at 10 Times the Rate of Inflation
April 2nd 2018Last week, Senator Claire McCaskill, D-Missouri, together with the minority staff of the Senate Homeland Security and Government Affairs Committee (HSGAC), released a report on prescription drug price increases that affect the 20 products most commonly prescribed to seniors.
FDA Fears USP's Monograph Changes Could Discourage Biosimilars
March 29th 2018One of the more serious concerns the FDA has discussed is the possibility that a developer of a proposed biosimilar could be deterred from seeking approval of its product, because United States Pharmacopeial Convention's (USP) proposed changes could complicate the licensure of a proposed biosimilar that meets the approval requirements of the FDA but does not match the USP’s standards of a monograph.
Gottlieb: FDA Working on "A Dozen Policies" on Biosimilars
March 29th 2018FDA Commissioner Scott Gottlieb, MD, indicated that the agency would be putting forward policies that would compel branded drug makers to “tighten up their manufacturing, to have less variance of their biologics that are currently on the market.” In theory, this change could make it easier to develop a biosimilar using smaller studies.
Without Policy Changes, a Stable Biosimilars Market "May Not Flourish"
March 28th 2018A new brief from Avalere Health argues that, if a multisource market for biologic drugs is to emerge in the United States, originator biologics and biosimilars must be able to gain market share commensurate to the value they offer to the healthcare system, and a variety of policy options are available to create the necessary conditions for true competition.
Policy Barriers Limit Biosimilar Access in Some European Nations
March 27th 2018While biosimilars have made significant inroads into the European marketplace, there remain hurdles to the adoption of these lower-cost drugs, especially in lower-income nations; external reference pricing can mean that drugs are priced to wealthier European countries’ financial capabilities, and manufacturers’ launch strategies may bring biosimilars to nations with the greatest market potential first.