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Expert Sees Biosimilars as Integral to Expanding Access, Controlling Costs in Oncology

Caroline Seymour
Published: Monday, Jul 16, 2018

Yelena Novik, MD

Yelena Novik, MD

The field of oncology may not be sustainable from a cost perspective without greater use of cost-saving agents, like biosimilars, and the development of more cost-efficient approaches to new drug development, said Yelena Novik, MD, an associate professor at NYU Langone’s Perlmutter Cancer Center.

Regulatory advances regarding biosimilars have been coming into the oncology field. In December 2017, the FDA approved the trastuzumab biosimilar MYL-1401O (Ogivri; trastuzumab-dkst) for use in patients with HER2-positive breast cancer in addition to HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma. Several other trastuzumab (Herceptin) biosimilars are under investigation.

More recently, results from the phase III HERITAGE trial presented at the 2018 ASCO Annual Meeting showed that the addition of MYL-1401O to a taxane as first-line therapy followed by MYL-1401O maintenance mirrored the progression-free survival rate at 48 weeks compared with trastuzumab in patients with HER2-positive metastatic breast cancer.2

Over the course of 48 weeks, the PFS was very similar at 11.1 months (P = .842) and reflected similar confidence intervals (MYL-1401O, 8.81-11.20; trastuzumab reference, 8.60-11.20). The hazard ratio graded by taxane, tumor progression, and tumor endocrine status for 48-week PFS was 0.95 (95% CI, 0.714-1.251; P = .694).

In an interview during the 2018 OncLive® State of the Science SummitTM on Breast Cancer, Novik shared her thoughts on the use of biosimilars in oncology and their potential impact on practice.

OncLive: What are your thoughts on the use of biosimilars in oncology?

Novik: I'm a big proponent of getting available drugs to every patient on earth, and biosimilars offer some hope. Biosimilars are being developed as growth factors and are already being used in practice. There is [also] hope for anti-HER2 therapy. Some of them have been approved by European regulatory societies and hopefully [they will be approved in the United States]. There is a lot of hope that these drugs will become available in parts of the world where they are not currently available. That could change breast cancer outcomes in many countries where [these medications are] not available now.

I'm a big proponent of this, but it's a difficult subject as a whole. I'm not an expert in pharmaceutical legislation, but the science really allows us to produce similar agents. We all understand patent law, but the vast majority of my colleagues will vote for biosimilars. We want to be sure that these drugs produce the same effect. The quality assurance process is difficult, but we will go ahead for biosimilars. It may be a difficult process, especially for this country.

Where do you think the hesitance toward biosimilars is coming from?

Biosimilars are different from generic drugs in the complexity of production. Chemicals have a particular kind of quality assurance process in production. Biosimilars are a kind of biologic drug, so the whole creation and production process of the molecule is somewhat different. Having been involved in clinical trials for a big part of my career, [I know that] clinical trials are so expensive now. Trying to reproduce something off of an identical molecule costs so much without bringing any additional intellectual contribution to society.

It’s a conundrum. We also understand our regulatory agencies, like the FDA, cannot inspect every factory that is producing drugs on a daily basis. It's a very complex issue, but we need to also have available drugs for the population. Our primary responsibility is our own population, but in general, the goal of oncology is to provide the world population with the best treatments possible.

Is the field of oncology sustainable without biosimilars?

You're asking very good questions, and we don't have very good answers. We all believe in progress, and we all believe [in developing] new treatments. We understand there is a need for investment to develop new treatments. However, in my opinion, the way they're being developed is absolutely unsustainable.

I'm very excited that we have new drugs, but the out-of-pocket cost is ,000 a month. If you or I needed to pay out of pocket, we would not be able to afford it. These are not the most expensive drugs either. Even by the time you develop a biosimilar, which also takes millions of dollars, a biosimilar at best will cost 30% less than regular drugs. Everything so far is unsustainable. I don’t know when it will become sustainable.

These are big problems, and luckily there are biosimilars that are being developed...We know about biosimilar growth factors for anti-HER2 therapy. I don’t know if there will be biosimilars for immune-based therapy or checkpoint inhibitors.

We [nonetheless] need to dream and think about it. The same [goes] for cell cycle inhibitors. [I wonder whether] anybody will try to produce a similar drug [for cell cycle inhibitors]. I happen to know somebody who was involved with this type of research at the beginning of this century. The project kind of went on the shelf for many years before it was picked up and became [what it is now]. I'm sure there is some possibility of those agents becoming generic.


  1.  Lyman GH, Balaban E, Diaz M, et al. American Society of Clinical Oncology statement: biosimilars in oncology. J Clin Oncol. 2018;36(12):1260-1265. doi: 10.1200/JCO.2017.77.4893.
  2.  Manikhas A, Pennella EJ, Bondarenko I, et al. Biosimilar MYL-1401O monotherapy versus trastuzumab monotherapy after combination therapy: Toxicity, efficacy, and immunogenicity from the phase 3 HERITAGE trial. J Clin Oncol. 2018,36 (suppl; abstr 110).

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