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China-based drug maker Henlius has announced that the European Medicines Agency (EMA) has accepted for review the company’s marketing authorization application for a trastuzumab biosimilar, HLX02, referencing Herceptin.
Drug maker Alexion, developer of the rare disease drug eculizumab (Soliris), announced Friday that the FDA has accepted for priority review its long-acting C5 complement inhibitor, ravulizumab (Ultomiris), which offers less frequent administration than eculizumab. 
Slow uptake of biosimilars, among other factors, will help propel drug spending over the next 7 years, according to a report released this week by PwC’s Health Research Institute (HRI).
 
The Center for Biosimilars® recaps the top stories for the week of June 17, 2019.
Biocon’s biologics facilities in Bengaluru, India, have received an EU certification of good manufacturing practice (GMP) after a March 2019 inspection, said the drug maker last week in a notice to the National Stock Exchange of India.
 
The Center for Biosimilars® recaps the top stories for the week of June 10, 2019.
Drug maker Genentech, developer of the brand-name rituximab, Rituxan, has announced that the FDA has accepted a supplemental Biologics License Application for the drug’s first proposed pediatric indication: 2 rare forms of vasculitis.
The 2 companies say that they will focus on biosimilars of originator products that will face patent expiry in 2025 to 2030.
“This systematic literature review found that the overall economic impact of biosimilar [nonmedical switching] remains uncertain,” write the investigators. More real-world studies will be necessary, they indicate, to quantify the full economic impact of nonmedical switches over the short and long term.
This week on the podcast, we're speaking with regulatory attorney James Shehan, JD, chair of regulatory practice at Lowenstein Sandler, LLP. In a prior role, Shehan had a hand in crafting the language that became the Biologics Price Competition and Innovation Act, which set forth the legal standard for interchangeability. Shehan discusses what the newly released guidance means for developers, what he thinks about the upcoming transition of insulins to regulation as biologics, and his view on the potential for interchangeable insulin biosimilars.

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Health economics experts. Managed care professionals. Key clinical specialists. This is where the worlds of clinical, regulatory, and economical outcomes for specialized pharmaceutical biotechnology meet: The Center for Biosimilars is your online resource for emerging technologies, with a focus on improving critical thinking in the field to impact patient outcomes. We’ll discuss the current landscape for advanced health care management—reviewing emerging treatment paradigms, approaches, and considerations—all by authoritative industry voices.

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