Skylar Jeremias

Russia has rebuilt its pharmaceutical industry following the demise of the former Soviet-led government, and emerging companies such as Geropharm are looking for markets abroad.

Biosimilar companies may do themselves a disservice if they produce education materials that don’t address the needs of clinicians or blatently self-promote, according to Kathy Oubre, chief operations officer at Pontchartrain Cancer Center of Louisiana.

Because they will see greater savings, employers have greater incentive to embrace biosimilars than plan sponsors in the overall insured population. Employers can be advocates for policy changes that promote biosimilars by contacting legislators; they can organize email campaigns to reach lawmakers more easily.

The National Comprehensive Cancer Network (NCCN) Guidelines may help get biosimilars into circulation because the NCCN will recommend them for off-label uses.

Amid the coronavirus disease 2019 (COVID-19) pandemic, the FDA issued guidance stressing the importance that manufacturers notify it of discontinuations and manufacturing interruptions so that the agency can implement contingency measures.

Self-insured companies could have saved $407 million to $1.4 billion in 2018 had they switched completely from reference biologics infliximab and filgrastim to biosimilars.

During March, the FDA worked to mitigate drug quality issues potentially arising from the coronavirus disease 2019 (COVID-19) pandemic, established a new regulatory pathway for certain biologics, and launched a high-profile effort with the Federal Trade Commission to halt anticompetitive practices.

Two doctors call for interchangeability requirements for biologics to be waived for insulin products under the new regulatory pathway under the Biologics Price Competition and Innovation Act (BPCIA) of 2009.

Because biosimilars piggyback on much of the clinical work already done on the drugs they imitate, they can be brought to market for less money, and therein lies the savings potential for patients and health systems, according to Lee S. Schwartzberg, MD.

“We're always under the tyranny of the 10-year budgetary window that the CBO [Congressional Budget Office] models under,” said Rep. Michael C. Burgess, MD, R-Texas, in a discussion of the limitations of the US system for bringing biosimilars to the market.

Competition in the insulin market is expected to rise because insulin products will be approved under the regulatory pathway for biological products now that the transition period added to the Biologics Price Competition and Innovation Act (BPCIA) of 2009 has officially ended, the FDA said.

The American College of Rheumatology (ACR) has issued a list of recommendations for streamlining prior authorization to eliminate redundancy and improve access for patients.

Sheila Frame, US head of Marketing and Market Access and Patient Services for Sandoz, discusses her company’s growing portfolio, the pipeline of biosimilar drugs, and the need for a more robust biosimilars market in the United States.

Two new bills aimed at increasing access to biosimilars and saving billions of dollars in out-of-pocket costs have been introduced in Congress. Both have been referred to committees for further review.

As the coronavirus (COVID-19) pandemic unfolded and disrupted pharmaceutical production, a panel of experts advocated for better education and legislation surrounding biosimilars in order to improve uptake in the United States and create affordable alternatives for patients.

The Congressional Budget Office has estimated that the Grassley-Wyden bill regulating pharmaceutical prices would generate savings of more than $94 billion over the next decade.

In inflammatory rheumatic diseases, the nocebo effect may account for a portion of treatment failures among patients who were placed on biosimilars; however, discontinuations due to the nocebo effect can be difficult to diagnose due to the absence of diagnostic criteria, differences in pathologic backgrounds for each disorder, and the absence of specific neurochemical and neuroimaging studies, investigators found.

Even as the first bevacizumab biosimilar gained approval for marketing in China, data emerged from a phase 1 pharmacokinetic study comparing the biosimilar with its reference product (Avastin).

As regulators work to increase competition and lower costs in the insulin market, CMS has released a new Medicare model intended to lower co-pays for insulin products to a maximum of $35.

HHS Secretary Alex Azar discussed the future of biosimilars in the United States and the actions taken to ensure reductions in healthcare and prescription drug costs at the Biosimilars: Breaking Through the Barriers symposium in Washington, DC.

Two regulatory experts said in an editorial that suffixes for biosimilars can support adverse event reporting and build provider and patient confidence in biosimilars.

Although biosimilar insulins are available in Europe, there are none in the United States currently, although that is slated to change.

Only 24% of providers were comfortable with prescribing biosimilars for patients with inflammatory bowel disease (IBD).

Growing awareness of biosimilars, patent expirations, and demands to lower healthcare costs are combining to increase uptake over the next 3 to 5 years, according to a recent S&P Global Ratings report. Some pharamceutical firms stand to gain, while others are more exposed.

Both the capitalized research and development costs as well as the average cost of investments were higher than previous estimates from other researchers.

The FDA announced changes or updates to several policies. Chief among them: final guidance on a regulatory shift for insulin and certain other products.

The quantitative comparison study compared 4 different, commercially available enzyme-linked immunosorbent assays used in therapeutic drug monitoring to detect drug concentration and antibodies to infliximab in samples of drug diluted in serum.

Lichen planopilaris (LPP) is a type of scarring hair loss that occurs when lichen plaus, a relatively common inflammatory skin disease, affects areas of skin where hair grows. It destroys the hair follicle and replaces it with scarring, resulting in permanent hair loss. LPP’s causes and pathology are unknown.

The study compared the stool samples of patients with ulcerative colitis (UC) with patients with familial adenomatous polyposis. Both groups may have colectomies, but only the patients with UC have inflammation that may return even after surgery.

Although the US biosimilar market had a slow start, the booming industry in Europe shows the potential for the market here. However, in order to level the playing field, more policy changes and legislation are needed to prevent originator products from crowding out competitors.