On March 29th, 2019, Shanghai Henlius Biotech, Inc. (Henlius) and Nature Research, part of the Springer Nature, announced the signing of a MOU for strategic cooperation, aiming to promote better understanding of biosimilar medicines to a boarder audience through a variety of cooperative projects including custom publishing and forums. Nature Research is the publisher of Nature, the leading international weekly journal of science, a range of Nature branded journals and other high quality academic journals.
Many pharmaceutical companies recently ventured into the development of biosimilars and were passionate about generating greater accessibility for patients. As a substitute, biosimilars are highly similar to the reference medicine with minor variations which contribute no clinically meaningful difference. Due to the complexity of their structure and physiochemical characterizations, biosimilars are developed with stepwise approach comparing to the reference medicine aided by the state-of-art analytical technologies. In the preclinical and clinical stages, the mechanism of actions of biosimilar and reference medicine were carefully examined; comparable pharmacokinetics and pharmacodynamics were developed as well as similarity of efficacy and safety profiles.
In early 2000, European Medicines Agency (EMA) pioneered in publishing the first biosimilar guideline. In the following years, a total of seventeen biosimilars have been approved in Europe categorized into five different monoclonal antibodies, which are adalimumab, infliximab, rituximab, bevacizumab and trastuzumab.
Clinical Significance and Current Status of Biosimilar
Dr. Huiqiang Huang, the Vice Chair of Internal Medicine, Sun Yat-Sen University Cancer Center (SYSUCC), gave presentation on The Current Status of Lymphoma in China and the Clinical Significance of Biosimilar. He emphasized the abundant clinical trials and the real-world evidence studies demonstrated rituximab plus standard chemotherapy improved the overall survival rate in patients with non-Hodgkin’s lymphoma. The approval of rituximab significantly decreased the death rate of this patient group.
Dr. Zhefei Jiang, Chair of Internal Medicine, the Fifth Medical Center of People’s Liberation Army General Hospital, presented The Current Status of Breast Cancer in China and the Clinical Significance of Biosimilar. He pointed out that trastuzumab, the medicine changed the history of HER2-positive breast cancer treatment and became the standard therapy for patients with metastasis HER2-positive breast cancer in China, has reversed the survival rate of HER2-nagative to HER2-positive breast cancer patients with a strong efficacy.
Accelerating the Development of Biosimilar
Despite the well-established efficacy and safety profiles, the accessibility of biologics was limited due to their high price of the drugs. The usage of biologics created financial burden for patients, their families and the healthcare system. According to the lymphoma in China 2017 survey, most of the patients were from low-income family, of those 88% had an annual income below 200,000 CNY (~$ 30,000 USD). For the patients receiving the treatment of biologics, 40% had to pay a large amount of out-of-pocket, which were three times higher than their annual family income.
In recent years, China pharmaceutical companies accelerated the development of biosimilars for unmet demands and hoped to increase the competition as well as lower the market price. In 2015, China National Medical Products Administration (NMPA) published the technical guideline for the development and evaluation of biosimilars (Drafted) to establish the regulatory requirements of biosimilars.
Henlius was founded by oversea research scientists together with Shanghai Fosun Pharmaceutical Co. Ltd. HLX01, manufactured by Henlius in China, was the first biosimilar approved by NMPA and granted with same indications to reference rituximab for the treatment of non-Hodgkin’s lymphoma.
Promoting the Understanding of Biosimilars
Unlike Europe and the United States, biosimilars were introduced in China much later. Dr. Scott Liu, the co-founder and CEO of Henlius, stated in the ceremony, “as the first company obtained the approval of biosimilar in China, we owe the responsibility to healthcare professionals, patients and regulators for a scientific understanding of biosimilars. The collaboration with Nature Research will provide qualified education to general audience, and finally patients can make consented-decision to receive affordable treatments.”
Dr. Paul Evans, Director of Nature Research Greater China, said: “Beyond publishing high quality research, Nature Research provides a wide range of services to facilitate the spread of knowledge and help our customers enhance their brand reputation and impact, leveraging our expertise and global network. We’re pleased to forge such a partnership with many research institutions in China and also a growing number of commercial companies like Henlius.”
Dr. Alvin Luk, Senior Vice President and Chief Medical Officer, Henlius stated there will be two major projects of cooperation. Firstly, a Nature Outlines will be published in May to explore the growth potential and challenges facing the biosimilar market in an easy-to-understand way, such as through infographics, illustrations, etc. Secondly, both sides will work together to host a Nature Research Round Table Conference scheduled around this June for healthcare professionals, pharmaco-economic scholars, regulators and policy makers, etc. to come together, discussing and exchanging knowledge and ideas about biosimilars. This event is expected to have five keynote speakers from both home and abroad in the fields of oncology, clinical study, pharmaco-economics and regulation who will deliver speeches from different perspectives to inspire further discussions on biosimilars in China.
Shanghai Henlius Biotech, Inc., a joint venture company co-founded by Fosun Pharma and a team of overseas scientists in February 2010, with its R&D footprint in Shanghai, Taipei, China and California, USA, specializes in the discovery, development, manufacturing and commercialization of high-quality biologics including biosimilar, bio-better and novel monoclonal antibody, to treat tumor and auto-immune disease.
Until now, Henlius has completed IND/CTA filings of 13 products and 2 combination therapies with 23 indications and obtained 29 successful IND/CTA approvals (19 approvals from China; 3 from the United States; 3 from Taiwan，China; each 1 from the European Union, Ukraine, Philippines and Australia). The first product of Henlius HLX01(rituximab injection) has granted approval by the China National Medical Products Administration (NMPA) as the first approved biosimilar in China and another important product of Henlius HLX03 has its New Drug Application under review.
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