Samantha DiGrande


Amgen Files Cross-Appeal in Ongoing Battle Over Epoetin Alfa

November 05, 2018

Amgen filed a cross appeal in this long-running case on October 15, 2018. The appeal challenges, among other things, the district court’s previous judgement that Hospira had not infringed on another patent named in the original suit, US Patent Number 5,756,349, which covers the production of erythropoietin.

Congressional Report Makes Recommendations to Decrease Insulin Prices, Includes Follow-on Products

November 03, 2018

In a recently published bipartisan report, representatives Diana DeGette, D-Colorado, and Tom Reed, R-New York, co-chairs of the Congressional Diabetes Caucus, released findings from a year-long inquiry into the sources of ever-increasing insulin prices.

Are Rumors of AbbVie's Humira Price Cuts What They Seem?

November 02, 2018

In an effort to combat competition from biosimilar adalimumab products in Europe as patents covering the reference product expired last month, AbbVie, developer of Humira, is reportedly prepared to offer a substantial discount. However, many European nations have policies that require a mandatory reduction of the reference product’s list price after biosimilar entry.

Pfizer Drug Pricing Will Return to "Business as Normal" in 2019

November 01, 2018

On an earnings call earlier this week, Pfizer CEO Ian Read said that the company will be returning to “business as normal” on its drug pricing in January, after having agreed to hold off on price increases earlier this year following pressure from the Trump administration.

Former Genentech Employees Charged With Stealing Trade Secrets for Biosimilar Competitor JHL

October 31, 2018

According to the United States Attorney's Office, Xanthe Lam, a principal scientist at the Roche Holding AG unit from 1986 until 2017, conspired with her husband and fellow former employee Allen Lam, and John Chan, another former Genentech employee, to steal trade secrets over the course of 5 years related to the biopharmaceutical dornase alfa (Pulmozyme) and some of Roche’s top-selling cancer drugs: rituximab (Rituxan), trastuzumab (Herceptin), and bevacizumab (Avastin).

Biosimilar Filgrastim Proves Noninferior to Reference in PBCM

October 29, 2018

A recent study presented at the Annual Scientific Meeting of the British Blood Transfusion Society, held in Brighton, United Kingdom from October 3-5, 2018, sought to determine the impact of introducing biosimilar filgrastim (sold in the United Kingdom as Zarzio) on the number of patients who were able to achieve target CD34 yield in peripheral blood stem cell mobilization (PBCM).

Secukinumab Expands Label in EU, Approved to Increase Dosing in Treatment of PsA

October 27, 2018

Secukinumab’s growing number of indications and its body of positive data may help it to compete for a substantial share of the inflammatory disease market against an increasing number of US- and EU-approved biosimilars, including 4 recently launched adalimumab biosimilars in the European Union.

Stakeholders Respond to the US Administration's International Pricing Index Proposal

October 27, 2018

Yesterday, the Trump administration released a new plan aimed at reducing Medicare’s costs for prescription drugs. Under the plan, CMS would be able to set its prices for some drugs, including biologics, based on the prices paid in other nations. Since the announcement, several stakeholders have spoken out about the proposed change.

As Reassuring Data on Anticancer Biosimilars Grow, ESMO Ups Its Biosimilar Education

October 24, 2018

The European Society for Medical Oncology (ESMO) 2018 Congress, held October 19-23, 2018, in Munich, Germany, featured multiple presentations on biosimilars in oncology, all of which are contributing to the body of evidence that points to the safety and efficacy of these products. Despite such reassuring data for biosimilars, however, many stakeholders have noted that lack of provider education on biosimilars is holding back progress with uptake.