Regulatory

FDA Approves Third Trastuzumab Biosimilar, Ontruzant

January 19th 2019

By Samantha DiGrande

The FDA has approved Samsung Bioepis’ Ontruzant (trastuzumab-dttb), a biosimilar trastuzumab referencing Herceptin, for the treatment of HER2-positive breast cancer and HER2 overexpressing gastric cancer.

The Top 5 Biosimilars Articles for the Week of January 14

January 18th 2019

The Center for Biosimilars® recaps the top news for the week of January 14, 2019.

New Paper Seeks to Clarify the US Position on Interchangeability

January 18th 2019

By Kelly Davio

A new paper, published this week in Current Medical Research and Opinion, seeks to clarify the US definition of interchangeability and differentiate it from the separate concepts of automatic substitution and physician-mediated switching.

As No-Deal Brexit Becomes More Likely, Drug Makers Warn of "Immediate Threat" to Patients

January 17th 2019

By Kelly Davio

After the UK Parliament voted to reject Prime Minister Theresa May’s proposed Brexit deal with just weeks to go before the United Kingdom’s planned withdrawal from the European Union, the pharmaceutical industry has warned that a no-deal Brexit poses “tangible and immediate threats” to patient safety and public health.

Government Shutdown Could Take a Substantial Toll on Biosimilars, Experts Say

January 16th 2019

By Kelly Davio

When the shutdown ends, said Scott Lassman, JD, partner at Goodwin, “It’s not going to be like flipping a switch…this is going to have longer-term consequences.”

Klobuchar and Grassley Reintroduce Legislation to Address Pay-for-Delay Tactics

January 16th 2019

By Samantha DiGrande

Senators Amy Klobuchar (D-Minnesota) and Chuck Grassley (R-Iowa) recently reintroduced bipartisan legislation aimed at bringing down prescription drug costs.

House to Investigate High Drug Costs for Humira, Enbrel, and Lantus

January 15th 2019

By Kelly Davio

The House Committee on Oversight and Reform has launched a wide-ranging investigation into prescription drug pricing in the United States.

Alexion's Second C5 Complement Inhibitor Requires Less Frequent Dosing, Carries New Patents

January 12th 2019

By Allison Inserro

Eculizumab must be administered every 2 weeks, versus every 8 weeks for the newly approved ravulizumab. Another possible advantage for Alexion is that the newer drug also has the benefit of new patent exclusivities that could help Alexion stave off the impact of competition from oncoming eculizumab biosimilars.

Celltrion Says Its Biosimilar Has Gained 56% of the European Infliximab Market

January 11th 2019

By Kelly Davio

Biosimilar developer Celltrion has seen strong success with its biosimilar infliximab, CT-P13, which is marketed in the United States as Inflectra and in other territories as Remsima. This week, the company said that its product has captured 56% of the infliximab market in Europe as of the third quarter of 2018.

Hospital Group Making Generic Drugs Adds 12 Additional Members

January 11th 2019

By Allison Inserro

Civica Rx, the nonprofit generic drug company formed last year by 5 health systems in order to combat drug shortages and high prices for generic drugs, added 12 additional health systems this week, bringing the total to 750 hospitals in the United States joining the venture so far.