Kelly Davio

August 30, 2019

In the oncology realm, August 2019’s biggest business development was the forward momentum of Amgen’s 2 newly debuted oncology biosimilars, and perhaps the biggest news in the biosimilar space from the inflammatory disease perspective also involved Amgen and its involvement in a long-running patent dispute.

August 29, 2019

Amgen, maker of the brand-name pegfilgrastim (Neulasta), and Mylan, which partnered with Biocon to develop a biosimilar (Fulphila), have entered a joint status report in the District Court for the Western District of Pennsylvania.

August 28, 2019

A new paper published this month may help to allay some concerns that US providers may have about using FDA-approved biosimilar rituximab.

August 28, 2019

In a filing with the US Securities and Exchange Commission this month, Silicon Valley-based biotech company Revance Therapeutics said that it has entered into an amendment to a Collaboration and License Agreement with Mylan; the amendment extends the period of time Mylan has to decide whether to continue to develop and commercialize a biosimilar of Allergan’s onabotulinumtoxinA (Botox).

August 27, 2019

A Japanese postmarketing surveillance study of biosimilar infliximab CT-P13 (Inflectra, Remsima) concludes that the biosimilar and its reference, Remicade, are comparable in terms of efficacy and adverse drug reactions in patients with inflammatory bowel disease (IBD) and that the biosimilar is a cost-efficient option that is interchangeable with the reference in real-world practice.

August 26, 2019

Administering the brand-name pegfilgrastim (Neulasta) via an on-body injection device (sold as Onpro) carries some risk of device failure, resulting in a missed or partial dose of pegfilgrastim. A recent cost simulation found that, when taking this failure into account, assured prophylaxis with biosimilar filgrastim offers the greatest cost efficiency.

August 26, 2019

A more compelling rationale for switching medications—particularly in light of “marginal” cost savings provided by biosimilars in the United States—is necessary, says the guideline.

August 23, 2019

A new report from Matrix Global Advisors and the National Business Group on Health, sponsored by Boehringer Ingelheim, shows that employers could see substantial savings from biosimilars, but those savings won’t come without a concerted effort to encourage biosimilar use.

August 23, 2019

The study in patients with non-Hodgkin lymphoma (NHL) is the second of a pair of studies intended to facilitate regulatory submissions for the proposed biosimilar.

August 22, 2019

When Samsung Bioepis’ trastuzumab biosimilar, SB3 (Ontruzant), gained regulatory approval in multiple highly regulated markets, it did so on the strength of a data package including evidence from a phase 3 study in patients with HER2-positive early breast cancer. Later, it became apparent that some of the patients who received the reference product in the phase 3 study had been exposed to lots of Herceptin with a marked shift in relative antibody-dependent cell-mediated cytotoxicity (ADCC) activity.