Patents for biologic agents first marketed in the 1980s are now beginning to expire, opening
the door for 'nonproprietary'versions of these agents to enter the market. However, there are …

With the projected expansion of the biosimilars market, there will be an increased propensity
for the substitution of reference biological products with cheaper biosimilars for economic …

Biosimilars are copies of reference biological drugs, developed as the patents for original
biologicals expire. They are thus developed to replicate an original biological medicine just …

Broader discussions around use of PD biomarkers occurred at an FDA and Duke Margolis
Center for Health Policy public workshop in 2021, which is summarized by Florian I et al i.[2] …

Importance of the field: Expiration of patents covering biopharmaceuticals, has provided
opportunities for pharmaceutical companies to develop, produce and market biosimilars or …

Importance of the field: Ever since the formation of the first biotechnology company almost
three decades ago, more than 150 biopharmaceutical products have been marketed across …

Patents for the first generation of approved biopharmaceuticals have either expired or are
about to expire. Thus the market is opening for generic versions, referred to as …

Biologic therapies have revolutionized treatment of a number of diseases. Patents and
exclusivity for a number of biologics are expiring. This has created the opportunity for the …

Purpose An update on scientific and regulatory challenges in the rapidly evolving field of
biosimilar product development is presented. Summary The US market for biosimilar …

Biopharmaceuticals based on recombinant proteins have started to go off-patent, opening
the way for other manufacturers to place follow-on products to the market. Meanwhile it has …