biosimilars
-
What CVS Stands to Gain by Setting Up Biosimilar Subsidiary Cordavis
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.
-
MedCity Influencers, BioPharma
The Crucial Role of Medical Affairs in Bridging the Educational Gap Among Healthcare Professionals in Biosimilars
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
-
Payer’s Place: Dawn Maroney
Dawn Maroney, President, Markets of Alignment Health and CEO of Alignment Health Plan, to discuss how they are using technology to provide better service and care to consumers.
-
Three pharmacy trends that will define 2022
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.
-
Teva’s generic label not skinny enough to protect from $234M damages to GSK
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.
-
Sandoz loses challenge to patent on Amgen’s $5.2B autoimmune drug, may appeal to Supreme Court
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.
-
MedCity Influencers, BioPharma
Navigating biosimilar reimbursement: Key challenges and steps to success
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.
-
A short history of drug patent expirations
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.
-
Merck to spin off drugs worth $6.5B into new company
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.
-
FDA, FTC look to crack down on tactics that they say thwart biosimilars
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.
-
Applying Remote Patient Monitoring to Surgery Prep and Recovery, Oncology and Women’s Health
Join us to learn about the latest trends in remote monitoring and how to extend its benefits beyond chronic conditions to more patients – all while using fewer staff resources.
-
These drug patents are expected to expire in 2020
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.
-
FDA hopes to spur insulin biosimilar development with easier clinical trial requirements
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.
-
Why is biosimilar adoption slow in the U.S., and can something be done to boost uptake?
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.
-
USPTO agrees to Amgen’s petition to review Alexion’s patents on rare disease drug
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.
-
A decade after biosimilars pathway’s creation, FDA issues final interchangeability rules
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.
-
MacroGenics’ stock price more than doubles on successful breast cancer study
In a conference call with analysts, the company’s CEO was tight-lipped about the median improvement in PFS, but the results nevertheless beat many investors’ expectations.
Promoted
Payer’s Place: Dr. Anil Singh
Dr. Anil Singh shares his insights into the strategies employed by the organization to identify the most effective digital solutions for their members.
Promoted
Discover the Next-Gen Platform for Integrated Collaborative Care
Beyond EHRs and digital front doors, reducing the gaps in patient care journeys.
