Amgen, Allergan achieve endpoints in ABP 215 biosimilar candidate study

In phase 3 trials, Amgen and Allergan’s biosimilar ABP 215 proved that it works similarly to Avastin, both in terms of outcomes and reported adverse events.

Amgen Inc and Allergan Plc said a late-stage study showed their biosimilar candidate for a type of lung cancer was as effective as Roche AG’s Avastin in preventing disease progression and improving survival.

The randomized, double-blind, active-controlled study (n=642) was conducted to evaluate the safety and efficacy of ABP 215 in comparison to Avastin, in adults suffering from advanced non-squamous non-small cell lung cancer (NSCLC) receiving first-line chemotherapy with carboplatin and paclitaxel. The primary endpoint of objective response rate was within the specified margin compared to bevacizumab, showing clinical equivalence.

Amgen and Allergan are now focusing on NSCLC, but will most likely go after the other Avastin indications as well. Amgen will, however, take the lead in developing and commercializing the product.

Amgen’s head of research and development Sean Harper said in prepared remarks Wednesday that nonsmall-cell lung cancer is the leading cause of cancer deaths in the USA and the European Union among both men and women.

The goal is to eventually compete with a cancer treatment that brought in about $6.6 billion for Roche previous year, a 6% increase over 2013.

We are encouraged by the positive results on ABP 215.

However, Amgen itself is facing biosimilar competition in the U.S. Zarxio, the first FDA-approved (Mar 2015) biosimilar, was launched by Sandoz earlier this month.

Similar, but less expensiveIn 2011, the two companies teamed up to develop four biosimilars that could eventually capture billions of dollars in market share away from top-selling biologic medicines, including Avastin, which is manufactured by Roche Holdings (NASDAQOTH:RHHBY).