What is your understanding of the use of biosimilars?

I know it’s a hot topic; I know I’ve been to quite a few [continuing education sessions, CEs] on it. At [Indiana University] it has not been necessarily a big topic of discussion. We have pretty much stuck with the products we’ve been using. But I think in the future, hopefully with more knowledge of biosimilars and everything we can kind of define a clear cut “when we should use what,” and how we interchange those products. It’s definitely a gray area at the moment.

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Julianne Orr, outpatient oncology clinical pharmacist, Indiana University Health, explains that biosimilars remain a gray area for pharmacists.

Julianne Orr, PharmD: Biosimilars Still a Gray Area for Pharmacists

Do you see biosimilars being used more in the future?

The use of biosimilars coming to the market will be challenging. As you know, biosimilars take a lot of research and development to develop the biosimilar, so the cost savings are probably not going to be as dramatic as some people may expect. I think biosimilars will have a challenge when going up against the branded product. The reason I say that is, number 1, they’ll have to be, certainly, price-advantaged to switch to a biosimilar from a branded product, but there are other things that go into product delivery, and that can be patient assistance programs. I believe that biosimilars will have to have the same programs in place as the brands do for people to embrace their products and bring them on board.

I would say that certainly the clinical data that we’ll review will solidify our use of the biosimilars—I think they’ll be used&mdash;[but] I think there’s going to be a price break point that we [will] need to achieve widespread adoption of biosimilars. I think you’re going to need to have really significant cost reductions for practices to switch to biosimilars, and we’ll have to see where that goes.

Steven D’Amato, RPh, executive director and clinical pharmacy specialist at New England Cancer Specialists, explains the factors that he feels will impact adoption of biosimilars.
 

Steven D'Amato, RPh: Adoption of Biosimilars

We are currently using biosimilars. We’ve actually created an approval process that we accept biosimilars as an acceptable product. We have brought in the first biosimilar; we use the product Zarxio in place of Neupogen. We did a full review of the product—a clinical review, the manufacturing process of it&mdash;and made a decision based on efficacy, safety and of cost-savings.

Howard Cohen, RPh, MS, FASHP, director of oncology pharmacy services for Yale New Haven Hospital, discusses using biosimilar filgrastim.

Howard Cohen, RPh, MS, FASHP: Using Biosimilar Filgrastim

Do you see any potential for regulatory agencies, such as the FTC, to weigh in on anti-competitive practices in the biologics and biosimilars world?

Absolutely. I can’t comment on whether they’re going to come in on a particular issue, but they’ve been very active in this area already. Years ago, when there were questions about the Hatch-Waxman Act and whether companies were abusing the patent listing process, they did a big study and actually commented to the FDA and spurred the FDA to change their regulations.

Most recently, they’ve been very active in the biosimilar and REMS area. There have been lawsuits by generic companies who could not get samples from the brand purportedly because the REMS prevented it. The FTC has come in with amicus briefs, they’ve come in with amicus briefs on some of the biosimilar issues, so they’ve actually been very, very active on this and I would expect that to continue in the future.

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, discusses the role that the Federal Trade Commission (FTC) may play in encouraging biosimilar competition. 

Scott Lassman: The FTC and Biosimilar Competition

How are biosimilars going to affect patients with rheumatic diseases?

CreakyJoints, and its parent organization, the Global Healthy Living Foundation, welcomes biosimilars to our treatment landscape. We expect the cost savings to affect the patients’ bottom line—their wallets or their pocketbooks&mdash;and we as a community will embrace all treatments to manage our disease because we remember life before these treatments, and we’re optimistic and hopeful for our lives as a result of these treatments.  

Seth Ginsberg, co-founder and president of the Global Healthy Living Foundation, explains that his organization welcomes biosimilars to the treatment landscape.

Seth Ginsberg: Biosimilars and Rheumatic Diseases

What do you want biosimilar developers to know about patients with inflammatory diseases?

There remains an unmet need for safe and effective treatments for inflammatory diseases. We support the research, development, and marketing of biosimilars to our community and related patient communities.

There are no words that can accurately summarize what biologics have meant to our community of patients. They have changed our lives. I remember when we created CreakyJoints back in 1999, from my dorm room bunk bed in the first year of college. We began by holding community-based patient events in libraries and community centers all around the country. One thing that sticks out in my mind is the instruction we’d give the meeting planners for those events—they’d set up 100 chairs for the event, but right before it started, pull the front right quadrant of 25 chairs so we’d make room for people with mobility assistance devices like wheelchairs or walkers.

Today, when we hold a patient event, if there is 1 wheelchair, it’s the outlier. This is directly the result of the innovation that has occurred with biologics, and biosimilars represent the continuation and proliferation of that innovation for our community.

As the next wave of therapies—in the form of biosimilars&mdash;comes to market, we must all work together to ensure that the cost savings that are realized by these versions of the treatments make their way to the patients’ purses and wallets.

Seth Ginsberg, co-founder and president of the Global Healthy Living Foundation, explains what biosimilar developers should know about patients with rheumatic diseases. 

Seth Ginsberg: What Biosimilar Developers Should Know About the Rheumatic Disease Community

In your experience, are value frameworks, such as those developed by NCCN and ASCO, being implemented in clinical practice?

I think value frameworks are being implemented in practice. I think people use guidelines internationally and that they find them very helpful and important.

Interestingly, sometimes people are so concrete with the guidelines [that] it results in more peer-to-peer reviews for patients because they’ll say, “Well you know, you can’t get that drug because it said that they only had 2 lines of therapy there and that patient had 3 lines.” And then we’re like, “Well, it’s not going to make that big of a difference.” Or, they only had 1 and it said the trial was only done in patients that had 2 lines of therapy. You can become very, very concrete in terms of how you interpret those guidelines.

Overall, I think guidelines are important, they give a consensus approach, they take the literature and best practices and provide that information for busy practitioners who are treating many different cancers and provide them essentially with back up.

Also, the guidelines generally provide patient-friendly forms of their guideline information, and that’s incredibly important. We want our patients to be educated as much as possible about what options exist, and it allows patients potentially to participate more in shared decision-making, and to understand when the decisions don’t fit those guidelines.

Hope Rugo, MD, director of the breast oncology clinical trials program at the University of California at San Francisco, discusses guidelines for the treatment of cancer.

Dr Hope Rugo: Value Frameworks and Clinical Practice

What are the key differences between the process for resolving patent disputes under the Biologics Price Competition and Innovation Act (BPCIA) and under Hatch-Waxman?

I’m a regulatory attorney, so I’m going to address it from the perspective of a regulatory attorney. [Intellectual property, IP] attorneys could give you a number of different answers, but I think there’s really 4 main differences.

The first one is for biosimilars, there’s no patent linkage. What I mean by that is, the approval of the application does not depend on the patents. For Hatch-Waxman, there is patent linkage. If a company does not want to challenge a patent, they have to get what’s called a paragraph 3 certification and they cannot get approval for that application until the patent expires. Even if they want to challenge the patents, there’s something called a 30-month-stay, which delays approval of the application until the patent litigation runs.

For biosimilars, there’s no patent linkage. There are processes for resolving patent disputes, but those are completely separate from whether or not FDA will approve the product. That difference is something that FDA specifically requested when the legislation was passed because one of their biggest headaches is the whole Hatch-Waxman patent process. For biosimilars, they just wanted to stay completely out of that.

The second big difference is that there’s no list of patents for biosimilars. So, for small molecule drugs, you’ve got the FDA orange book. In that publication, the FDA lists all of the patents that apply to the brand product. For biosimilars, FDA has what’s called a purple book, but that does not include any of the patents. The idea is that the patents will be identified and litigated through the process that Congress set out. That’s another main difference.

I guess I said there were 4, now I’ve only got 3 [laughter]. But the third difference I would say is the BPCIA, the biosimilar patent process, is actually much more complex than the Hatch-Waxman requirements. I actually didn’t think Congress could come up with something more complex, because the Hatch-Waxman provisions are 

 complex, but they exceeded my wildest expectations and they’ve included an unbelievably complex process for biosimilars.

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, discusses the differences between patent litigation for biologics and biosimilars under the BPCIA and small-molecule drugs and their generics under the Hatch-Waxman acts.

Scott Lassman: The BPCIA Versus Hatch-Waxman Litigation

What are some trends in state-level legislation concerning substitution of biologics?

Transparency and safety are big themes at the state-level concerning substitution of biologics. We want physicians and patients to be aware of any changes or substitutions that occur. Ultimately, we believe that in order for biosimilar uptake to be successful, confidence needs to be established in the patient and physician communities. This can only happen through transparency. Thirty-six states and Puerto Rico* have passed patient-friendly legislation that, now by law ensures that a doctor and patient are informed of a substitution, and if for some reason a doctor doesn’t think it’s appropriate, they have the opportunity to prevent the substitution.

Seth Ginsberg, co-founder and president of the Global Healthy Living Foundation, discusses trends in state laws that address the eventual substitution of interchangeable biosimilars for reference biologics.

Seth Ginsberg: Trends in State-Level Legislation on Biosimilar Substitution

Do you foresee the FDA stepping in to clarify issues concerning the BPCIA?

Well, they have issued a number of guidance documents and draft guidance documents. I think they’re going to continue to finalize the draft guidance documents they’ve got out there. I don’t think there’s a lot more on the horizon.

The question about [whether they’re] going to do something in response to the court cases is another interesting question; I actually don’t think they are.

The 1 thing they could do, it would be easy, and this is to me the 1 thing they might do, is they could basically say that for biosimilars there is such a thing as tentative approval. That would address some of the issues that have been swirling around as to when you can give the notice that you’re going to start marketing.

That would be very consistent with what they do with [abbreviated new drug applications, aNDAs] and what they do with 505b2 applications, so I don’t think that would be much of a stretch for them. But they really do not want to get involved in any of this BPCIA litigation. I know the courts and some of the litigators are trying to pull them in; I think they’re going to push back and try not to get roped in. At least that’s my guess.

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, discusses whether the FDA might involve itself in answering the lingering questions concerning the Biologics Price Competition and Innovation Act (BPCIA).

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