Kelly Davio

January 02, 2018

Republic of Korea–based drug developer Polus has sold $9.37 million in convertible bonds to its affiliate Amnis.

January 01, 2018

Mylan and Biocon ended 2017 with more positive news for their biosimilar program; on December 29, 2017, the partnership announced that Brazil’s National Sanitary Surveillance Agency (ANVISA) had approved their trastuzumab biosimilar.

January 01, 2018

Bevacizumab is employed cautiously in patients with multifocal glioblastomas rather than single glioblastomas because of a fear, based on unconfirmed preclinical data, that bevacizumab can increase the invasive tumor phenotype.

December 30, 2017

A new paper argues that the addition of a single data element—namely, a batch or lot number—would enhance the value of pharmacovigilance systems for biosimilars.

December 28, 2017

While 2017 was a busy year for biosimilar approvals by the FDA, Rick Lozano, vice president of biosimilars and integrated business development at AmerisourceBergen, feels that the biggest developments in biosimilars were those being made outside the regulatory or clinical spheres. In an interview with The Center for Biosimilars®, Lozano said that “There are distractions and defense strategies in the market that continue to be slowing the pace” of bringing biosimilars to the market.

December 27, 2017

In clinical practice, biologics are routinely used for medically accepted off-label indications, and these uses are typically curated by guidelines. A newly published study, led by Edward Li, PharmD, MPH, BCOP, argues that the FDA’s framework for granting the extrapolation of indications for biosimilars can be used by clinicians and payers to determine appropriate off-label uses of biosimilars.

December 26, 2017

According to Marcus Snow, MD, assistant professor of internal medicine in the division of rheumatology, University of Nebraska Medical Center, some of the most critical developments in the biosimilars space during 2017 were the result of payer decisions.

December 25, 2017

While more biosimilars gained regulatory approval 2017 and neared their entry into the US marketplace, physician acceptance of these products proved to be a challenge.

December 23, 2017

The European risk management plan (RMP) contains relevant safety information for specific products, with characterizations of both potential and identified risks, including real-world data. Because the RMP is systematically updated, the RMP can provide early indications of differences in product safety between originator and biosimilar therapies.

December 22, 2017

Developments at the FDA and greater physician acceptance of biosimilars made 2017 a banner year for emerging therapies, according to James Stevenson, PharmD, FASHP, professor of clinical pharmacy at the University of Michigan College of Pharmacy.