Biologic agents are currently the fastest emerging segment of drug expenditure. Unlike
chemically synthesized small‐molecule drugs, biologics are more complex, medicinal …

The coming wave of patent expiries of first generation commercialized biotherapeutical
drugs has seen the global market open its doors to close copies of these products. These …

Biologicals have become an integral part of cancer treatment both as therapeutic agents and
as supportive care agents. It is important to know that biologics are large, complex molecular …

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 …

As originator biologic medicines lose patent protection, some biopharmaceutical companies
are focusing on developing similar versions of these costly and complex therapies with a …

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 …

Biological product development for launch in multiple geographies with varied regulatory
expectations would require a planned and focused strategy, involving the selection of the …

It has been 17 years since the approval of the first biosimilar in Europe (Omnitrope®,
somatropin) and only 8 years since the approval of the first biosimilar in the US (Zarxio® …

Biologics play a key role in cancer treatment and are principal components of many
therapeutic regimens. However, they require complex manufacturing processes, resulting in …

This article discusses specific issues related to the market access of biosimilars.
Biopharmaceuticals are complex molecules produced by living cells. Copies of these …