Regulatory

CBO Says Bill to Curb Pay-for-Delay Would Cut the Deficit by $613 Million Over 10 Years

May 10th 2019

By Kelly Davio

The bill seeks to prohibit brand-name drug makers from delaying the entry of generics or biosimilars by compensating competitors to keep their products off the market for a period of time in so-called pay-for-delay arrangements.

The Top 5 Biosimilars Articles for the Week of May 6

May 10th 2019

The Center for Biosimilars® recaps the top news for the week of May 6, 2019.

Congress Votes on Amending Orange and Purple Books in Effort to Encourage Generics and Biosimilars

May 8th 2019

By Kelly Davio

The House of Representatives has passed a pair of bills that make changes to the FDA’s Orange Book and Purple Book, which provide information on generic drugs and biosimilars, respectively.

HHS Sets Details of Finalized Rule Requiring List Prices to Be Disclosed in DTC Ads

May 8th 2019

By Allison Inserro

In an effort to improve price transparency, the Trump administration on Wednesday announced a final rule requiring drug manufacturers to disclose their list prices for pharmaceutical products or biologics in television ads for drugs covered by Medicare or Medicaid if the wholesale acquisition cost is $35 or more for a month’s supply. Affected drugs include adalimumab (Humira), with its wholesale acquisition cost (WAC) of $5174 per month, and etanercept (Enbrel), with its WAC of $5174 per month.

In Comment Letters, Stakeholders Call on FDA to Change Course on Biosimilar Naming

May 8th 2019

By Kelly Davio

This March, the FDA released updated guidance on the naming of biologics, biosimilars, and interchangeable biosimilars. In the document, the FDA indicated that it no longer intends to retroactively give approved biologics 4-letter suffixes devoid of meaning, but it will continue to assign suffixes to newly approved innovator biologics, biosimilars, or interchangeable biosimilars. In addition, FDA does not intend to add suffixes to the names of transition products. This week, the comment period on the updated guidance closed, and the FDA heard from a variety of stakeholders who asked the agency to change its direction.

Specter of FTC Involvement Raised at Senate Hearing About Intellectual Property

May 8th 2019

By Allison Inserro

The idea of giving the Federal Trade Commission (FTC) more authority to cut through patent thickets blocking biosimilar competition was raised Tuesday during a hearing of the Senate Judiciary Committee about intellectual property, patent law, and the impact on drug prices.

Roche Gets a Boost from New Kadcyla Indication as US Biosimilars of Herceptin Near

May 7th 2019

By Kelly Davio

Yesterday, the FDA approved Roche’s ado-trastuzumab emtansine (Kadcyla) for the adjuvant treatment of HER2-positive early breast cancer in patients who have residual invasive disease after neoadjuvant taxane- and trastuzumab-based therapy. The new indication could help to stave off some of the impact of biosimilar trastuzumab, which is expected to launch this year.

CBO Single-Payer Report: Highlights of Drug Pricing, Cost Containment Ideas, Implications

May 3rd 2019

By Allison Inserro

The Congressional Budget Office this week released a report that examines the different components of what putting together a single-payer system could involve, as well as the implications. Here we highlight 2 sections of the report that are likely of interest to those following biosimilars, drug pricing and healthcare cost containment.

The Top 5 Biosimilars Articles for the Week of April 29

May 3rd 2019

The Center for Biosimilars® recaps the top news for the week of April 29, 2019.

2 Arrested in Samsung Bioepis Accounting Probe

May 1st 2019

By The Center for Biosimilars Staff

On Monday, the Seoul Central District Prosecutor’s Office in the Republic of Korea arrested an executive and another employee at biosimilar developer Samsung Bioepis for falsifying and destroying evidence and for violating audit law.