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While injectable drugs, including some innovator anti–tumor necrosis factor inhibitors and their biosimilars, have revolutionized the treatment of rheumatic diseases like rheumatoid arthritis (RA), hand disability can limit the ability of patients with RA to use syringes to administer medication. Prefilled, disposable auto-injectors may help to alleviate this issue and have demonstrated acceptability studies, but questions have remained about whether patients with reduced manual dexterity may still experience needle displacement when using these devices.

This week, Frost & Sullivan—a global researching and consulting organization—together with Rani Therapeutics, a drug manufacturer developing an approach to the oral delivery of large-molecule drugs, announced the results of a combined research study. The study suggested that biosimilar developers could gain market share from brand-name biologics by developing the biosimilars in oral form.

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.

Retinal vein occlusion (RVO) is a prevalent, vision-threatening disease, of which macular edema is a common complication. Standard treatment for RVO-associated macular edema involves intravitreal treatment with anti–vascular endothelial growth factor (anti-VEGF) agents such as ranibizumab, bevacizumab, or aflibercept. Despite success with these agents in clinical trials, anti-VEGF agents may be administered less frequently in clinical practice than in studies.

Jeffrey Capello, executive vice president and chief financial officer, divulged that Biogen intends to exercise its option to increase its stake in the Samsung Bioepis joint venture. Currently, Samsung BioLogics holds 94.6% of the company, and Biogen owns the remaining 5.4%.

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has released its Corporate Plan for the coming 5 years. The plan seeks to address some of the uncertainty generated by ongoing negotiations between the United Kingdom and the European Union in light of the upcoming Brexit.

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.

In a letter last week, patient advocacy group Patients for Affordable Drugs called on the Federal Trade Commission (FTC) to examine whether a pay-for-delay deal allegedly struck between reference adalimumab (Humira) manufacturer AbbVie with biosimilar developer Samsung Bioepis violates anti-competitive and antitrust laws.

Yesterday, the FDA’s Arthritis Advisory Committee convened for a vote on whether to recommend approval of Eli Lilly’s baricitinib, a Janus kinase (JAK) inhibitor that the company hopes to sell as Olumiant for the treatment of rheumatoid arthritis (RA). The advisory committee voted in favor of recommending approval of a dose of 2 mg and against recommending approval of a higher 4-mg dose because of concerns about safety, including the risk of thrombosis.

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.

A case series was recently published in CNS Oncology that investigated whether adult pilocytic astrocytoma—a rare and highly vascular tumor—is responsive to bevacizumab treatment.

Australia has been seeking to support the approval and uptake of biosimilar medicines as a way to alleviate pressure on its national health system.

After spinal cord injury, oxidative stress, inflammation, and mitochondrial dysfunction can cause neural damage that was once believed to be both immediate and irreversible. However, neuronal death is now believed to proceed over a period of several days after initial trauma, and to include cellular, molecular, and biochemical cascades, including local inflammatory responses. Tumor necrosis factor is believed to be involved in the local production of cytokines at the site of the injury.

Pfizer announced this morning that the FDA has issued a Complete Response Letter for PF-05280014, a proposed trastuzumab biosimilar referencing Herceptin.

This week, Scott Gottlieb, MD, Commissioner of the FDA, addressed the US House Subcommittee on Agriculture and Rural Development, Food and Drug Administration, and Related Agencies, and made his case for increased funding for the FDA.

At the American College of Rheumatology (ACR)’s State-of-the-Art (SOTA) Symposium, held last week in Chicago, Illinois, Judith James, MD, PhD, chair of arthritis and clinical immunology at Oklahoma Medical Research Foundation, presented a talk on precision medicine in rheumatology.

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

In the case study, the authors report findings from a comparability assessment of epoetin alfa before and after a proposed manufacturing process change for which, they say, nonclinical assessment of structure-function relationships were not sensitive enough to identify clinically relevant differences resulting from differences in the drug’s glycosylation profile.

Rheumatologists gathered from across the country last week to discuss the latest approaches in the treatment of rheumatoid arthritis (RA) and other inflammatory diseases at the American College of Rheumatology’s (ACR) 2018 State-of-the-Art (SOTA) Clinical Symposium held in Chicago, Illinois.

Since 2017, the Italian National Agency for Drugs has approved of the off-label use of infliximab and adalimumab for juvenile idiopathic arthritis-associated uveitis, and has created a patient registry to collect anonymized data from patients in 24 pediatric rheumatology and ophthalmology centers across Italy.

Over 370 centrally authorized products have been transferred to new rapporteurs located in the remaining 27 EU member states, Iceland, and Norway. The transfer followed a procedure developed by the EMA’s working groups on committees’ operational preparedness for both human and veterinary medicines in the wake of the United Kingdom’s withdrawal from the European Union.

Amazon Business has hit pause on its plan to sell and distribute pharmaceutical products to hospitals after investigating the possibility last year.

During a session at the 2018 Community Oncology Conference, hosted by the Community Oncology Alliance April 12-13 in National Harbor, Maryland, Robert M. Rifkin, MD, FACP, medical director of biosimilars at McKesson Specialty Health, The US Oncology Network, highlighted the opportunities biosimilars provide to increase access to drugs while decreasing costs, but also the remaining barriers to adoption.

Canadian patients who receive brand-name adalimumab (Humira) to treat ankylosing spondylitis (AS) are eligible for a patient support program, provided by drug maker AbbVie, that includes personalized services such as coaching phone calls before and after initiating treatment.

CMS established a lower maximum copay for biosimilar and interchangeable biological products that is equivalent to the lower co-pay required for generic and preferred multiple source drugs.

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.

The FDA has finalized its guidance on the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research special protocol assessments (SPA). SPA is a process in which product sponsors may ask to meet with FDA to reach an agreement on the design and size of clinical trials and clinical or animal studies to determine whether they adequately address the scientific and regulatory requirements to support eventual marketing approval.

The researchers found that a high proportion of microbiota of the Betaproteobacteria class and Burkholderiales order prior to treatment was associated with clinical response at 3 months.