Biological Drugs: Challenges to Access

By Amit Sengupta

Publisher: TWN
ISBN: 978-967-0747-26-2
Year: 2018   No. of pages: 44
14.5 cm x 21 cm

About the Book

This paper examines the landscape of biological medicines and locates this analysis in the characteristics of biological drugs which set them apart from small molecule drugs. These characteristics drugs which set them apart from small molecule drugs. These characteristics impact on the way biological drugs are manufactured; on the development of follow-on versions of innovator biological drugs; on the way biological drugs – both innovators and follow-ons – are regulated; on the way these drugs are protected by different kinds of intellectual property rights and data protection mechanisms; and on the opportunities and challenges in the introduction of biological drugs, including biosimilars, in a range of countries.

Dr Amit Sengupta has trained in medicine. His main interests include issues related to public health, pharmaceuticals policy, and other science and technology-related policy issue like intellectual property rights.

        Dr Sengupta has been associated with the People’s Science Movement in India and the People’s Health Movement (PHM) in India and at the global level. Currently he is the Associate Global Coordinator of PHM. He has overall responsibility for coordination of PHM’s Global Health Watch Programme and is the managing editor of Global Health Watch. Inter alia, he is responsible for coordinating PHM’s policy engagements and development of policy briefs and position papers, and for coordinating PHM’s engagement and networking with other social movements and networks, including the World Social Forum process.


1.      The Growing Therapeutic and Commercial Importance of Biologics              

2.      How Biological Drugs Differ from Small Molecule Drugs                            

3.      Recombinant Technologies in the Manufacture of Biological Drugs               

4.      Renewed Interest in Biological Medicines                                       

5.      Why Are Biologics and Biosimilars So Expensive?                   

6.      Biosimilars vs Generics of SMDs: Different Treatment by Regulators

7.      Technological Barriers to Manufacture of Biosimilars                       

8.      Barriers Related to Intellectual Property Rights and Data Exclusivity

9.      The Evolving Regulatory Landscape for Approval of Biosimilars                  

10.     How Necessary Are Present Requirements to Establish Similarity?                

11.     Uptake of Biosimilars in Clinical Practice: Interchangeability and INN

12.     Conclusions            

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