Biological Drugs: Challenges to Access
- Malaysia: Third World Network, 2018.
- 38p.
978-967-0747-26-2
The Growing Therapeutic and Commercial Importance How Biological Drugs Differ from Small Molecule Drugs Recombinant Technologies in the Manufacture of Biological Drugs Renewed Interest in Biological Medicines Why are Biologics and Biosimilars So Expensive Biosimilas vs Generics of SMDs Technological Barriers to Manufacture of Biosimilars Barriers Related to Intellectual Property Rights and Data Exclusivity The Evolving Regulatory Landscape for Approval of Biosimilars How necessary are Present Requirements to Establish Similarity