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 development and approval of biosimilars. Biosimilars are biologic products developed using a step-wise approach to result in a biologic that demonstrates no clinically meaningful differences in terms of quality attribu...

Since ancient times plant and animal tissues have been used as medicines. In the 20th century growth hormone as a purified extraction from human pituitaries was still used to treat growth disorders. Since the genetic engineering of host cells became possible, a new generation of medicines obtained using recombinant DNA (rDNA) technology has emerged. These medicines have been named ‘biopharmaceu...

The development of genetically modified (transgenic) animals for the production of human recombinant therapeutic proteins has been ongoing for more than 25+ years. Only recently in the last few years have products finally been approved that can now be found commercially on the market to the benefit of the medical community and patients that receive these lifesaving therapies. rEVO Biologics has...

Gene therapy is a new therapeutic approach which is tested in numerous diseases connected with either non or only limited therapeutic effects. This paper aims at discussing the actual state of the clinical development of gene-therapy which targets an approval by either the FDA or EMEA. Basis of all the figures and tables presented is a BioMedNet/Medline search reviewing all titles found under t...

Bendamustine has achieved widespread international regulatory approval and is a standard agent for the treatment for chronic lymphocytic leukemia (CLL), indolent non-Hodgkin lymphoma and multiple myeloma. Since approval, the number of indications for bendamustine has expanded to include aggressive non-Hodgkin lymphoma and Hodgkin lymphoma and novel targeted therapies, based on new bendamustine ...

Therapeutic options for treatment of chronic hepatitis C have improved substantially since the approval of direct-acting antiviral agents (DAAs). Several interferon (IFN)-free or IFN- and ribavirin (RBV)-free treatment regimens with shorter durations and improved efficacy and safety profiles are now available. The U.S. Food and Drug Administration (FDA) used several scientific approaches and re...

Rucaparib camsylate (CO-338, AG-014699, PF-01367338) is a potent PARP-1, PARP-2, and PARP-3 inhibitor. Phase I and II studies demonstrated clinical efficacy in both BRCA-mutated (inclusive of germline and somatic) ovarian tumors and ovarian tumors with homologous recombination deficiency (HRD) loss of heterozygosity (LOH). Rucaparib has received the US Food and Drug Administration (FDA) approva...

As the first wave of biopharmaceuticals is set to expire, biosimilars or follow-on protein products (FOPPs) have emerged. The regulatory foundation for these products is more advanced and better codified in Europe than in the US. Recent approval of biosimilar Somatropin (growth hormone) in Europe and the US prompted this paper. The scientific viability of biosimilar growth hormone is reviewed. ...