Back to top

Image: Bigstock

Mylan/Biocon's Herceptin Biosimilar Phase III Data Published

Read MoreHide Full Article

Mylan N.V. and partner Biocon Ltd. announced that data from a phase III HERITAGE study on their biosimilar version of Roche Holding AG’s (RHHBY - Free Report) cancer drug, Herceptin (trastuzumab), MYL-1401O, was published in the Journal of the American Medical Association (JAMA).

Shares of Mylan have outperformed the Zacks categorized Medical-Generic Drugs industry year to date. The company’s stock has lost 30.7% during this period, while the industry witnessed a decline of 37.1%. Note that the industry is under immense pressure at the moment owing to the ongoing focus on drug pricing issues.

The double-blinded, randomized study was conducted to evaluate the efficacy, safety and immunogenicity of MYL-1401O, in comparison to Herceptin, in patients with HER2-positive metastatic breast cancer. Data showed that MYL-1401O demonstrated an overall response rate of 69.6% compared to 64% for Herceptin. Moreover, tumor progression, progression-free survival and overall survival were not statistically different between MYL-1401O and Herceptin at week 48.

These study results were presented at the 2016 American Society of Clinical Oncology Annual Meeting and the European Society for Medical Oncology Congress.

We remind investors that last month Mylan had announced the submission of a biologics license application for MYL-1401O in the U.S., making it the company’s first FDA biosimilar submission. Mylan believes it has the potential to be the first to seek approval for a biosimilar version of Herceptin in the U.S. Meanwhile, the biosimilar version of Herceptin is currently under review in the EU, and Mylan and Biocon believe that theirs is the first regulatory application for a Herceptin biosimilar to be accepted for review by the European Medicines Agency.

Upon approval, MYL-1401O could provide an effective treatment option for metastatic breast cancer patients at a lower cost.

Herceptin is approved for the treatment of certain HER2-positive breast and gastric cancers. It is one of Roche’s top-selling pharma products with 2015 worldwide sales exceeding CHF 6.5 billion, including sales of CHF 2 billion in the EU.

We note that collaborations with companies like Biocon and Momenta Pharmaceuticals, Inc. have helped Mylan develop a portfolio of additional biologics and insulin analogs that are currently in development. The biosimilar version of Herceptin is one of the six biosimilar programs being co-developed by Mylan and Biocon. Biosimilar versions of Neulasta and insulin analog of Lantus are currently under review in the EU. The companies also plan to seek FDA approval for a Neulasta biosimilar.

While Mylan has exclusive commercialization rights for the Herceptin biosimilar in the U.S., Canada, Japan, Australia, New Zealand, and in the EU and the European Free Trade Association countries, Biocon holds co-exclusive commercialization rights with Mylan for the same in the rest of the world.

MYLAN NV Price and Consensus

 

Mylan currently carries a Zacks Rank #3 (Hold).

A Key Pick

Adamas Pharmaceuticals, Inc. is a better-ranked stock in the industry carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

Adamas’ loss estimates narrowed from $3.16 to $3.11 for 2016 and from $3.02 to $2.90 for 2017 over the last 60 days. The company posted a positive surprise in three of the four trailing quarters with an average beat of 9.02%. Its share price has surged almost 26% year to date.

Zacks' Top 10 Stocks for 2017

In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-hold tickers for the entirety of 2017?

Who wouldn't? As of early December, the 2016 Top 10 produced 5 double-digit winners including oil and natural gas giant Pioneer Natural Resources which racked up a stellar +50% gain. The new list is painstakingly hand-picked from 4,400 companies covered by the Zacks Rank. Be among the very first to see it>>


See More Zacks Research for These Tickers


Normally $25 each - click below to receive one report FREE:


Roche Holding AG (RHHBY) - free report >>

Published in