October 7th 2025
The latest advancements in global biosimilar access include new treatments, strategic partnerships, and competitive market entries enhancing patient care.
Mylan Receives FDA Form 483 Noting 13 Inspection Observations
July 10th 2018Last week, the FDA issued a 32-page Form 483 to Mylan after a 5-week inspection of its manufacturing plant in Morgantown, West Virginia. The FDA cited 13 inspection observations, including failure to follow proper quality control protocols, lack of adequate cleaning of utensils and equipment, and ineffective laboratory controls and sampling, among others.
FDA Draft Guidance Explains Assessment of User Fees Under BsUFA
July 9th 2018The FDA recently released a draft guidance document entitled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.” The guidance is meant to address various industry inquiries around the implementation of the Biosimilar User Fee Amendments II (BsUFA II).
Canada Allows Aligned Regulatory Drug Reviews Between Health Canada and HTA Orgs
June 29th 2018Health Canada, Canada’s governmental health agency, announced that there is now an option for all biological and pharmaceutical new drug submissions to request aligned regulatory reviews between Health Canada and health technology assessment (HTA) organizations.
Addressing Concerns Around Interchangeable Biosimilars
June 26th 2018Although no biosimilar has earned an interchangeable designation by the FDA to date, the distinction could garner more biosimilar uptake. In a presentation during the American Conference Institute’s Summit on Biosimilars, held June 25-27 in New York, New York, various stakeholders discussed how interchangeability is the future of the space.
Eye on Pharma: Progress for Celltrion on Trastuzumab and Subcutaneous Infliximab Biosimilars
June 18th 2018Korean drug maker Celltrion has announced that it has resubmitted its Biologics License Application for CT-P6, a trastuzumab molecule referencing Herceptin. Separately, Celltrion announced new data for its proposed subcutaneous formulation of its flagship biosimilar, CT-P13, an infliximab biosimilar referencing Remicade, in patients with rheumatoid arthritis.
Survey Shows Trust in Healthcare Systems Declining Globally
June 18th 2018The survey found that, for the United States specifically, in the informed public segment, there was a 20% drop in the general trust in healthcare, giving the United States market the second biggest drop following Colombia. Globally, trust declined in 16 of 28 markets studied, noting an average 4% decline in trust in healthcare globally.
More Biosimilars on the Market Could Decrease Drug Prices, Panelists Say
June 16th 2018In a webcast hosted by the Alliance for Health Policy that took place earlier this week, Robert Langreth, senior health reporter for Bloomberg News, Dora Hughes, MD, MPH, senior policy advisor at Sidley Austin, LLP, and Sameer Awsare, MD, associate executive director of the Permanente Medical Group at Kaiser Permanente, came together to discuss the best ways to bring down the steadily increasing drug prices in the United States. The panel was moderated by Mary Ella Payne, RN, MSPH, president of the Alliance for Health Policy.
Second Patent Cliff Lies Ahead for Pharma With $251 Billion in Sales at Risk by 2024
June 7th 2018EvaluatePharma, a company that provides consensus forecasts of the pharmaceutical and biotechnology sphere, recently published its 11th edition of its World Preview. In this 2018 installment, the company provided an overview of what investors and other stakeholders can expect to see in the industry from 2018 to 2024.
Eye on Pharma: Celltrion to Develop Novel Drugs Alongside Biosimilars
June 6th 2018Republic of Korea-based biosimilar developer Celltrion, maker of Inflectra, has announced that it will launch a contract development and manufacturing business to develop novel agents alongside its biosimilar pipeline.
FDA Draft Guidance Clarifies Meeting Types for Biosimilar Applicants
June 5th 2018This week, the FDA released a draft guidance document titled “Formal Meetings Between the FDA and Sponsors or Applicants of [Biosimilar User Fee Act] BsUFA Products.” The guidance offers clarification to industry members on the procedures and specifications of formal meetings with the FDA.
Celltrion Reports Positive Phase 1 Results for Subcutaneous Inflectra in CD
June 5th 2018Celltrion presented new research that demonstrates that a formulation of its infliximab biosimilar intended for subcutaneous administration is comparable to the intravenously administered option. The phase 1 study compared the subcutaneous formulation—which can be self-administered—with the FDA-approved intravenous formulation in patients with active Crohn disease (CD).