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Business & Regulation Biosimilars, Business Practice, Trends & Forecasts

Business in Brief

  • The UK’s Cell and Gene Therapy Catapult has opened a manufacturing center in Stevenage, UK. The center was backed by over £60 million from the UK government and has the infrastructure to develop manufacturing capability for large scale cell and gene therapy clinical studies. The center will also supply the network of world-first, UK-based Advanced Therapies Treatment Centers, which will develop and deliver the therapies. 
  • A new R&D center is on the cards for WuXi AppTec, which has just signed an investment agreement with the government of Shanghai Jinshan District in China. The new center will be located next to the existing Jinshan drug substance manufacturing site, and will add more than 30,000 square meters of laboratory space and 500 scientists.
  • In the US, Mayne Pharma has opened a new $80-million facility, which will quadruple the company’s capacity to manufacture oral solid-dose pharmaceuticals. The facility is located in Greenville, North Carolina, and can also cope with the commercial scale manufacture of potent compounds.
  • Sandoz’s rituximab biosimilar application to the FDA has been rejected. The company received a complete response letter in early May. The reasons for the rejection have not been disclosed. “While disappointed, Sandoz remains committed to further discussions with FDA in order to bring this important medicine to US patients as soon as possible,” Sandoz said in a statement. Rituximab was approved by the EMA in June 2017 and is marketed as Rixathon. 
  • Herzuma, a biosimilar trastuzumab (Herceptin), is now available in Europe for the treatment of early breast cancer. It is the third biosimilar to be marketed and distributed by the Mundipharma network in Europe. Marketing authorization was granted in February 2018. 
  • A report from (Biosimilars Market by Product, Manufacturing Type and by Disease – Global Forecast to 2023) has forecast the global market for biosimilars to grow at a CAGR of 31.7 percent, to reach $23.63 billion by 2023. The non-glycosylated proteins segment accounted for the largest market share of the market in 2017; however, recombinant glycosylated proteins are expected to hold the largest share of the market during the forecast period.
  • PARADIGM is a new collaboration between 34 public and private partners, launched to make “meaningful patient engagement in the life cycle of medicines a reality”. PARADIGM stands for Patients Active in Research and Dialogues for an Improved Generation of Medicines, and is funded by the EU’s Innovative Medicines Initiative. It is described as an open forum on patient engagement.
  • AstraZeneca is collaborating with Lucy Cavendish College at Cambridge University to help women advance in science and business leadership. Employees will mentor students by supporting their scientific developments and offering career and personal development advice.
  • A public inquiry will begin in the UK later this year on the tainted blood scandal of the 1970s and 1980s, when more than 3000 people were infected with HIV and Hepatitis C. Campaigners are pushing for the inquiry to examine the role of pharmaceutical companies.
  • Biohacker Aaron Traywick, CEO of Ascendance Biomedical, has died. Traywick was known for developing and self-administering CRISPR-Cas9 gene editing technologies – and even injected himself with an untested herpes cell therapy in front of a live audience earlier this year. The cause of death has not yet been revealed.
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About the Author
Stephanie Vine

Making great scientific magazines isn’t just about delivering knowledge and high quality content; it’s also about packaging these in the right words to ensure that someone is truly inspired by a topic. My passion is ensuring that our authors’ expertise is presented as a seamless and enjoyable reading experience, whether in print, in digital or on social media. I’ve spent fourteen years writing and editing features for scientific and manufacturing publications, and in making this content engaging and accessible without sacrificing its scientific integrity. There is nothing better than a magazine with great content that feels great to read.

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