BOGOTA, Colombia – Mylan NV's Ogivri (trastuzumab) has become the first registered biosimilar in Colombia, to be marketed by Strenuus Marketing, a Bogota-based drug distributor.

"We want to be part of the policy that the Ministry of Health has implemented, through which it is giving a much more agile process to products whose patents have already expired and have been a monopoly in the Colombian market," Alexander Correa, commercial director at Strenuus, told BioWorld.

Despite Correa's optimism for the future, Ogivri's path to registration was a lengthy one. It took Strenuus about five years to register the drug produced by Mylan, of Canonsburg, Pa., but the company is confident that the registration process will be sped up going forward. This is the first drug registered using specific regulations tailored for biosimilars in Colombia.

"We want our company to be part of those first biosimilars that will allow significant savings to the health system that has been hit hard by the high costs incurred over the last 15 or 20 years," said Correa.

The Colombian company has already closed deals with 25 hospitals to distribute Ogivri, and the first batch of the biosimilar is already on the market, supporting patients with metastatic HER2-positive breast cancer and HER2-positive gastric cancer in the Latin American country.

"For many years HER2-positive tumors had a very poor prognosis. They were, together with triple-negative tumors, the tumors associated with the worst prognosis," said Mariana Chávez, associate professor at the University of Texas MD Anderson Cancer Center in Houston, during the launch event for Ogivri in Bogota. "This has changed radically, but it is not because the tumors are less bad; it is because we now have extraordinary treatments that have improved the clinical outcomes for our patients, and the reality is that all this began with the revolution that really generated the trastuzumab."

First approved in the U.S. for treating metastatic disease in 1998, trastuzumab today "is a standard part of the management of all patients with HER2-positive tumors," she added. "The clear message is that incorporating trastuzumab into chemotherapy improves the time free of recurrence in our patients."

Trastuzumab was jointly developed by Roche Holding AG unit Genentech, from South San Francisco, and the University of California, Los Angeles (UCLA). Roche, of Basel, Switzerland, held the patent that, in the U.S., expired last June.

Greater access for patients

This is not the first time Strenuus has worked with Mylan, a pharmaceutical company that closely follows the patent expiration of biologics and is focused on producing biosimilars. The company makes drugs at 47 manufacturing plants around the world, 19 of which are located in India.

"We have already had the experience of working with Mylan in the past. It is a laboratory with FDA and EMA approvals, and we are confident on their quality," said Correa.

"We continue in this race, and I believe that Ogivri is already achieving significant savings to the health system," he added.

Strenuus Marketing is also working on the registration of other biosimilars, including a biosimilar version of Neulasta (pegfilgrastim), a biologic produced by Amgen Inc., of Thousand Oaks, Calif.

Strenuus is also working on registering an undisclosed oncologic biosimilar, which the company aims to file registration for with Invima, Colombia's health surveillance agency, during the second half of 2020.

"Biosimilars are already a reality in Colombia and not only just through Strenuus; there are other multinational companies as well, which will also have their biosimilar approvals soon, and this is good news, as it will allow patients greater access to these medications, who currently have not been able to have these treatments due to the high cost," said Correa.

Colombia's Ministry of Health capped the price of trastuzumab in 2018 at COP$11.179 (US$3.31) per gram. However, according to Correa, Mylan's entrance into the market for the treatment of breast cancer and gastric cancer has already lowered the price of the drug by about 40%.

Breast cancer is the second most common type of cancer in Colombia, with an age-standardized rate of 44.1 cases per 100,000 inhabitants, according to the International Agency for Research on Cancer, from Lyon, France, a branch of the World Health Organization in Geneva.

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