As IRA provisions are activated, the law’s impact on biologics and biosimilars will become more apparent. By using both the carrot and the stick, the IRA may finally bolster the market, increasing uptake of biosimilars to benefit patients and help lower costs.
Pharmaceutical industry observers say CVS Health’s creation of Cordavis, a new biosimilar drugs company, is part of a strategy to make its move into this market as profitable as possible.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Biosimilars represent an important therapeutic option in modern healthcare, offering cost-effective alternatives to complex biological drugs. The educational gap among healthcare professionals poses a challenge to their widespread adoption. Medical Affairs teams in the pharmaceutical industry are at the forefront of bridging this gap
The pharmaceutical industry made more headlines in 2021 than in any other year in recent memory. And 2022 is set to be a monumental year as well.
When is a skinny label skinny enough to protect a generic drug from claims of patent infringement? The answer remains up to interpretation after an important, controversial decision from the Federal Circuit.
A federal appeals court upheld two key patents covering Amgen's Enbrel, thus further preventing Novartis' generics unit from launching its biosimilar. However, an analyst wrote that the probability of Sandoz overturning the decision is low.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
As the government has implemented step therapy in Medicare Advantage plans, and some commercial payers are preferring biosimilars, clarity around biosimilars and their reimbursement channels is paramount for providers and biosimilar pharmaceutical companies alike.
This eBook offers an overview of drug patents that were and are set to expire and highlights efforts by the FDA to stimulate the market for generics.
The company, currently labeled only "NewCo," will focus on Merck's women's health, legacy products and biosimilars, while Merck itself focuses on oncology, vaccines, hospital drugs and animal health. The drugmaker's shares fell more than 4% when markets opened Wednesday.
In a joint statement, FDA Commissioner Stephen Hahn and FTC Chairman Joseph Simons said they would look into anticompetitive practices like preventing biosimilar makers from obtaining product samples and misleading communications about biosimilars' safety and efficacy.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
According to a report, drugmakers are expected to lose $17 billion in worldwide sales due to patent expirations this year. Two reports list 18 drugs as losing patent protection or exclusivity, though not all drugs listed here will necessarily face generic or biosimilar competition in 2020.
In a draft guidance, the agency proposed guidelines reducing the need for clinical trials to test insulin biosimilars for the potential to provoke immune system reactions. European regulators stopped recommending immunogenicity trials for insulin biosimilars in 2015.
Although the pathway for biosimilars has existed nearly a decade, adoption has lagged behind Europe. Interviewed experts pointed to physician education and the market's immaturity as significant factors.
Shares of Alexion fell more than 11 percent Friday as the office instituted an inter partes review for the drug, Soliris, in the blood disorder paroxysmal nocturnal hemoglobinuria.
The rules are still more restrictive than the European Medicines Agency's, which allow national governments to determine interchangeability. The FDA would require additional testing to demonstrate products can be freely substituted like generic pharmaceuticals.