Mylan’s ‘Biosimilar’ Drug Comparable to Roche Cancer Medicine

Study Finds Mylan’s ‘Biosimilar’ Drug Comparable to Roche Cancer Medicine

Development marks milestone in effort to bring cheaper versions of cancer treatments to market.

Mylan Pharmaceuticals Inc. is developing Myl-1201O, which a study showed to be essentially equivalent in safety and effectiveness to Roche Holding AG’s Herceptin. PHOTO: GETTY IMAGES

Researchers said a drug being developed by Mylan Pharmaceuticals Inc. proved comparable to Roche Holding AG’s Herceptin in a clinical trial, a new milestone in the effort to bring cheaper versions of some of biotechnology’s best-known cancer drugs to the market.

In a study involving a total of 500 patients, Mylan’s drug, called Myl-1401O, was shown to be essentially equivalent in safety and effectiveness to Herceptin, a multibillion-dollar medicine that in the past two decades has transformed treatment for about 25% of breast cancer patients.

Mylan’s drug is a so-called biosimilar—the industry’s term for a copy of a biotechnology drug. The copy “has the potential to meet the need for an affordable treatment option” for women diagnosed with what is known as Her2-positive breast cancer, said Hope S. Rugo, lead author of the report and professor of medicine at University of California San Francisco. “We haven’t been able to deliver lifesaving therapies around the world because of cost,” Dr. Rugo said.

In a statement, Rajiv Malik, president of Mylan, said, “There is an urgent unmet need for more affordable versions of biologic products.” But the company declined to discuss its pricing plans. Mylan is developing the drug in collaboration with Biocon Ltd. of India, where the Herceptin copy is already on the market.

How much insurers may ultimately save with biosimilars is unclear. Unless there are multiple biosimilars for a single branded drug, prices are expected to drop by only 15% to 30% from the branded drug’s price. Another question is whether doctors and patients will be willing to switch to a biosimilar from Herceptin, an iconic breast cancer treatment.


Biotech drugs, which are typically injected or infused, are manufactured in living organisms, making them more difficult and costly to develop than standard pills made from chemicals. Showing that copies are essentially equivalent to the originals has also posed some scientific and regulatory challenges.

But the U.S. Food and Drug Administration and European regulators have recently established new regulatory criteria intended to create a market for biosimilars.

So far, the FDA has approved two biosimilar drugs under the initiative: Novartis AG’s Zarxio, which is similar to Amgen Inc.’s Neupogen for the treatment of side effects of chemotherapy; and Inflectra, a version of Johnson & Johnson’s Remicade treatment for arthritis and other conditions. Inflectra was developed by Korea’s Celltrion and licensed to Pfizer Inc.

Multiple companies also are developing biosimilar versions of other big-selling biologics that they hope to launch in coming years, including copies of AbbVie’s Humira arthritis treatment and Amgen’s Neulasta for chemotherapy patients.

Sellers of the original branded biologics are taking measures to protect their sales, including raising prices ahead of biosimilar competition and pursuing patent litigation to delay the competing products. These are among reason some experts have questioned just how much savings may actual result from approval of biosimilars.

Mylan is competing with several other companies to develop biosimilars for Herceptin. The new study is the first to show a biosimilar drug is equivalent to a biotech drug designed to attack cancer. Pfizer and Amgen are testing their own Herceptin biosimilars. Pfizer and Amgen are also among companies developing biosimilar versions of Roche’s Avastin and of Rituxan, from Roche and Biogen Inc.

Dr. Rugo said she believes data from such studies will be reported soon.

Ronny Gal, analyst at Sanford Bernstein, says he expects a Herceptin biosimilar could reach the market in Europe next year and the U.S. in 2018.

Roche and its Genentech unit didn’t have an immediate response to the new data. But in a commentary published on Genentech’s website Thursday, Myriam Mendila, Genentech’s head of U.S. medical affairs, said the company has “long-supported the FDA’s efforts to implement a science-based pathway” to approve biosimilars.

But she added that “biosimilars are not exact copies of the original medicines” and that as they reach the market “it will be important to closely monitor safety and effectiveness” to see if important differences in outcomes for patients result.

The new study evaluated patients with metastatic disease who were treated with chemotherapy for 24 weeks plus either Herceptin or the Mylan drug. Patients continued on the biotech drugs alone after 24 weeks until their disease progressed. At 24 weeks, the overall response rate was 69.6% for patients on the Mylan drug and 64% for those on Herceptin, a result considered essentially equivalent. Researchers said 36% of Herceptin patients and 38% of those on the Mylan drug had serious adverse events. There were four deaths in each arm of the study.

The patients were from Eastern Europe, Latin America and Asia, areas of the world where patients generally haven’t had access to drugs such as Herceptin because of the cost.

“We don’t know what the cost is going to be [in the U.S.] or whether there will be a big drop in cost,” said Dr. Rugo. “One thing that will absolutely happen is that there will be better access to the drug world-wide.”


source: Wall Street Journal