Kelly Davio

October 05, 2018

“Comparison of estimated prices with recent government procurement prices suggests that robust competition in the human insulin and insulin analogue market would lead to sizeable savings in most countries and that current manufacturers could set significantly lower prices while still making a profit,” write the study’s authors.

October 04, 2018

The FDA this week announced revised draft guidance that it says will help ensure that citizen petitions cannot be used by brand-name drug makers to delay the market entry of generics or biosimilars of branded products.

October 03, 2018

The study randomized and dosed 589 patients with breast cancer with either the biosimilar, the EU-licenced reference pegfilgrastim, or the US-licensed reference pegfilgrastim.

October 03, 2018

Pfizer indicated that Nivestym will be priced at a wholesale acquisition cost (WAC) of $350.40 per 480-mcg prefilled syringe, a WAC that is 30.3% lower than that of the reference Neupogen.

October 02, 2018

Momenta Pharmaceuticals announced that after a strategic review of its operations, the company will refocus on novel therapeutics rather than on biosimilars.

October 01, 2018

Health Canada has approved a formulation of Roche’s originator trastuzumab, Herceptin, that is intended for subcutaneous administration. The drug, indicated to treat HER2-positive cancers, can be administered in 2 to 5 minutes (versus an average of 90 minutes for intravenous administration).

September 30, 2018

From the FDA’s hearing on the Biosimilar Action Plan to European approval of the first pegfilgrastim biosimilars, September was a banner month in biosimilar regulation.

September 28, 2018

In the United States, biosimilar launches have been met with disappointment over what many view as too-shallow discounts to reference products’ list prices. However, as Aurelio Arias, a consultant at IQVIA, explained during the SMi 9th annual conference on Biosimilars and Biobetters, held September 26-27 in London, United Kingdom, the substantial savings that the European market has realized with biosimilars are not necessarily reflected in list prices, either.

September 28, 2018

Recent weeks have seen heightened debate over the need for phase 3 confirmatory trials for biosimilars, with some stakeholders calling these trials unnecessary and others going so far as to call them unethical. During the SMi 9th annual conference on Biosimilars and Biobetters, held September 26-27 in London, United Kingdom, Uwe Gudat, MD, who serves as head of clinical safety and pharmacovigilance at Fresenius Kabi, weighed in. “The subject I raise is rather provocative,” he acknowledged.

September 27, 2018

While every biologics manufacturer has its own standards against which it measures a product’s consistency over time, there is an increasing need for harmonization of these in-house standards with a public standard that can serve as a benchmark for the reference product and all biosimilars. This, explained Meenu Wadhwa, PhD, is where World Health Organization (WHO) international standards come in.