Policy

The Center for Biosimilars® recaps the top 5 articles for the week of May 14, 2018.

Scott Gottlieb, MD, commissioner of the FDA, who has been vocal about "shenanigans" used by innovator drug makers to forestall competition from biosimilars and generics, today announced the publication of a list of companies that have restricted access to samples of small-molecule drugs for testing through the use of Risk Evaluation and Mitigation Strategies programs or limited distribution of their products.

This comment period is important for biosimilar stakeholders because the Trump administration's plan has addressed specific efforts being made by the FDA and HHS to improve biosimilar development, approval, education, and access.

Data from new CMS dashboards reveal that many of the drugs that have seen the highest annual growth in spending per beneficiary over the 2012 to 2016 period are products that either currently face or will soon face biosimilar or follow-on biologic competition.

This week, the Commonwealth Fund released new findings from its Affordable Care Act Tracking Survey. The survey is a nationally representative telephone poll that tracks coverage rates among 19- to 64-year olds.

HHS’ “American Patients First” blueprint for implementing Trump’s vision includes a proposal to address the potential misuse of Risk Evaluation and Mitigation Strategy programs to delay biosimilar competition.

The Center for Biosimilars® recaps the top 5 articles for the week of May 7, 2018.

In an interview with The Center for Biosimilars®, Dennis Cryer, MD, physician co-convener of the Biologics Prescribers Collaborative (BPC), said, "We still feel that much of the effectiveness of therapy is the relationship and the trust that can be developed between the physician and the patient."

The United States Patent and Trademark Office (USPTO), in a proposed rule published today on the Federal Register, seeks to amend the rules for inter partes review proceedings, and similar proceedings, before the Patent Trial and Appeal Board.

The report’s authors assessed commercial plan coverage and formulary design concerning biosimilars for the top 25 payers—covering approximately 189 million lives—in the United States, using publicly available policies.

Tahir Amin, DipLP, co-founder and director of intellectual property of Initiative for Medicines, Access, and Knowledge, discusses the link between drug patents and innovation.

The Center for Biosimilars® recaps the top 5 articles for the week of April 30, 2018.

During a session at the Academy of Managed Care Pharmacy’s (AMCP) Managed Care & Specialty Pharmacy Annual Meeting, held April 23-26 in Boston, Massachusetts, Reginia Benjamin, BS, JD, director of legislative affairs for AMCP, provided an in-depth look at state legislation on biosimilars.

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

The 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.

While 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.

The 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.

The 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.

In 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.

The Center for Biosimilars® recaps the top 5 biosimilars articles for the week of April 16, 2018.

At 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, 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.

Last week, a federal appeals court in Maryland ruled that a law, passed in 2017 and aimed at combatting increases in the price of generic medicines, is unconstitutional.

This 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.

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

In 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.

In 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.

Limited 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.

In 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.

The 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.