FDA Urges Manufacturers to Promptly Report Supply Problems Amid COVID-19 ChallengesApril 2nd 2020
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.
Biosimilar Regulatory Roundup: March 2020April 1st 2020
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.
Physicians Urge FDA to Waive Interchangeability Standard for Insulin BiosimilarsMarch 30th 2020
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.
Schwartzberg: Biosimilars Are Complex But Still Cheaper to ProduceMarch 27th 2020
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.
Expert Panel Discusses Systemic, Policy Barriers to US Biosimilar UptakeMarch 25th 2020
“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.
FDA Officials Predict More Insulins Under New Biologics PathwayMarch 24th 2020
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.
Sandoz Executive Sees Positive Signs for Biosimilar UptakeMarch 20th 2020
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.
Amid COVID-19 Fears, Expert Panel Highlights Need for Biosimilars in the United StatesMarch 19th 2020
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.
Nocebo Effect Is Difficult to Diagnose in Patients Switched to BiosimilarsMarch 17th 2020
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.
HHS Secretary Alex Azar Expresses Hope in Biosimilar Uptake, Notes Positive MomentumMarch 11th 2020
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.
S&P Report Details Biosimilar Impact for Pharma Firms in Coming YearsMarch 6th 2020
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.
Assays Used to Monitor Infliximab Are Similarly Effective for Biosimilars SB2, CT-P13February 28th 2020
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.
Study: Adalimumab Plus Hydroxychloroquine Leads to Hair Regrowth in Lichen PlanopilarisFebruary 27th 2020
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.
Researchers Suspect Link Between Missing Gut Microbes, Ulcerative ColitisFebruary 25th 2020
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.
Looking Forward: 2020 Expected to Be Major Year for Biosimilar MarketFebruary 21st 2020
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.
AbbVie: Next-Generation Skyrizi and Rinvoq Are Showing Traction in Humira SpaceFebruary 21st 2020
Pharmaceutical giant AbbVie reports strong revenues for next-generation products the company hopes will provide fill-in revenue as Humira (adalimumab) sales decline and more biosimilars to the blockbuster arthritis drug enter the market.
Office of Pharmaceutical Quality Report: Key Deadline Looming for BPCIAFebruary 18th 2020
The Office of Pharmaceutical Quality, charged with strengthening and building public trust in the US supply of medicine, notes that March 23, 2020, will mark a key turning point in the way that many biologics are licensed.
Follow-on Insulin Glargine, Generic Glatiramer Illustrate Medicaid Drug Rebate Issue, Study SaysFebruary 17th 2020
Which Medicaid plans benefit the most from the current drug rebate structure and are incentivized to prescribe branded prescriptions? Researchers used the issue of follow-on insulin glargine as well as glatiramer acetate to find out.