FDA granted tentative approval to Merck for an insulin glargine follow-on pending the outcome of Hatch-Waxman litigation; does the fact that FDA regulates insulin as a drug have an impact on the litigation process?

I think it does. The Hatch-Waxman laws were enacted in 1984 and we’ve had a lot of practice with these litigations in the district courts and appellate courts, and the metes and bounds and contours of the Hatch-Waxman laws have been pretty well defined through decades of adjudication. It’s a pretty rapid and efficient timeline from [Abbreviated New Drug Application, ANDA] filing to final resolution of the appeal—pretty well-oiled litigation procedure. We have a lot more uncertainty with the [Biologics Price Competition and Innovation Act, BPCIA]. It’s a new statute, courts are just adjudicating it now for the first time, and we are seeing a lot of&mdash;I wouldn’t say confusion&mdash;but a lot of testing of the gray areas of the statute, for example, with 

. Litigants are really trying to take advantage of every perceived advantage in the statue and are bringing motions and are litigating those. So, the pace of litigation is likely to be quite a bit slower in the context of the BPCIA, at least initially. Also, we see a lot more patents typically being brought to bear in and BPCIA litigation. So, the fact that Lantus is being brought along this sort of well-oiled generic drug litigation track, I think [that] in general, although the specifics will vary from case to case, I think that in general that’s going to be a faster timeline right now, than BPCIA litigation.

Videos

Robert Cerwinski, JD, partner at Goodwin, explains why Hatch-Waxman litigation may provide a smoother path than does the Biologics Price Competition and Innovation Act. 

Robert Cerwinski: Hatch-Waxman Litigation of Follow-On Insulins

Oil States Energy Services v Greene’s Energy Group

 stand to change the IPR process in general?

It’s an interesting case in that there is a petition to the Supreme Court challenging the constitutionality of [inter partes reviews, IPRs]. IPRs have been one of the main tools in the tool kit of biosimilar applicants to try to clear a path for biosimilars to market. Everybody in the biosimilars world is watching this Supreme Court matter pretty closely. The upshot is, if in fact the law that created IPRs is governed to be unconstitutional, Congress is going to have to take another shot at either modifying or redoing the statute that created IPRs. So, the potential impact on biosimilar applicants from having the IPR scheme eliminated entirely will be quite significant. I don’t think anyone really expects IPRs to go away forever, but this is one of those cases where even if folks are feeling pretty comfortable that IPRs are at least in some respect constitutional and are here to stay, there is a risk that the IPR world as we know it could change in the near term—so we are watching it closely.

Robert Cerwinski, JD, partner at Goodwin, discusses a petition before the Supreme Court challenging the constitutionality of inter partes review. 

Robert Cerwinski: Oil States and the Inter Partes Review Process

Do pharmacy schools need to change their curriculum to address biosimilars? 

The pharmacy school curriculum should adapt to the growing increase in biosimilars by adding coursework to compare and contrast small molecules versus large, complex proteins, as well as approval process and requirements for bringing biosimilars to market. On rotation, pharmacy students should encounter biosimilars and have some experience with dispensing those agents.

Brandon Shank, PharmD, MPH, BCOP, Clinical Pharmacy Specialist, discusses the need for pharmacy schools to adapt their curriculum to address biosimilar treatments.

Dr Brandon Shank: Pharmacy School Curriculum and Biosimilars

Do “Pay-to-Delay” agreements affect biosimilars in the way they affect small-molecule drugs?

The FTC hasn’t really weighed in on that, and it’s really the [Federal Trade Commission, FTC] and the Department of Justice who have been driving a lot of the activity and the activism around pay-for-delay suits. The long and short is that policy is really kind of behind the Justice Department and the FTC’s concern about pay-for-delay. The basic proposition is that: We want to make sure that access to generic drugs happens as soon as possible, so we want to police settlements to make sure that the public is not being prejudiced by private settlements between generic drug companies and branded drug companies. The same policy rationale could very well exist with biosimilars. The policy behind the [Biologics Price Competition and Innovation Act, BPCIA] is at least roughly the same as the policy behind the Hatch-Waxman laws, which is: Let’s encourage early biosimilar entry by giving a mechanism for resolving patent infringement lawsuits prior to actual marketing—let’s incentivize both sides to get this dispute out of the way early, so that biosimilars can reach the market as soon as possible. So, because the policies behind the Hatch-Waxman laws and the BPCIA are roughly aligned, we may very well see some scrutiny by the Justice Department and the FTC of such settlements.

Robert Cerwinski, JD, partner at Goodwin, discusses the potential for government agencies to weigh in on pay-for-delay settlements in the biosimilars space.

Robert Cerwinski: Pay-for-Delay Settlements and Agency Scrutiny

Will there be reimbursement challenges with biosimilar products?

I think it’s too soon right now to say, exactly. It is a very complicated payer system, and there are a lot of incentives—for the hospitals, the patients, and the insurance companies. I hope that patients will see some of the cost savings, as well as insurances, and hospitals will be incentivized, hopefully, to add these agents on to their formulary and pass on the cost savings to the entire health care system both at a payer base and a patient-care level.

Brandon Shank, PharmD, MPH, BCOP, Clinical Pharmacy Specialist, discusses the potential for reimbursement challenges with biosimilars.

Dr Brandon Shank: Reimbursement Challenges With Biosimilars

What role will patient education play in the uptake of biosimilars in oncology?

I think it is going to be very interesting. I don’t think we know yet. I think that there is a question from a physician perspective and even a patient-centric perspective of how in-depth should a physician be. If the drug is approved, if the FDA has determined the drug to be not interchangeable but equivalent, and labeled for those indications, do you need to say more than the drug name and not the modifier that would identify it as a biosimilar? And I wonder if physicians will take that extra step, only because, is it patient-centric to do so? Are you going to convey to a patient risks that may not be there just because you’re defining a difference where the difference has been deemed immaterial?

Bruce A. Feinberg, DO, CMO, Cardinal Health Specialty Solutions, discusses the importance of patient education on biosimilar treatments. 

Dr Bruce A. Feinberg: Patient Education on Biosimilars

 have an impact on litigation for biosimilars?

 decision applies to patent infringement litigation, generally, and it concerns the patent venue statute. The issue in

 is: where can a patent infringement suit be brought against particular defendants?  Before 

was decided, the Federal Circuit had taken the position that anywhere that a defendant was subject to personal jurisdiction, either personal jurisdiction because it was the place where the defendant was incorporated, or had his principal place of business, or because there was specific personal jurisdiction, i.e. where the acts of jurisdiction occurred. The Supreme Court took a narrow view of the venue statute, or the venue provision in the patent statute, and said really a suit can only be brought where the patent defendant resides or where the acts of infringement have occurred and the defendant has a regular established place of business. The dispute in

was really: what does “reside” mean?  The Federal Circuit had taken the position that it’s anywhere the personal jurisdiction lay, and the Supreme Court said it’s just where the defendant is incorporated. So, the upshot of all of this is where particular defendants can be sued is now more limited in the context of patent infringement litigation. Interestingly, the Supreme Court did not weigh in on where foreign defendants can be sued. So, foreign defendants that aren’t really incorporated anywhere in the US—that question remains unanswered. As the reference product sponsors and biosimilar manufacturers jockey over where suits under the BPCIA should be adjudicated, which venues may be more favorable to the biosimilar applicant versus the reference product sponsor, now 

 is going to limit some of those choices.

Robert Cerwinski, JD, Partner at Goodwin, discusses the impact of the recent Supreme Court ruling in TC Heartland v Kraft on biosimilar litigation. 

Robert Cerwinski: The Impact of TC Heartland on Biosimilar Litigation

Could 4-letter suffixes to the names of biosimilars create confusion? 

I think one benefit of the naming system is that you know what the reference product is. I think some clinicians, pharmacists included, and patients may assume interchangeability, which may not be inferred by the naming system. I think it is important to have a way to differentiate these products so that you can know which ones are interchangeable, so that ones with different indications will also be recognized and not be used for the wrong indication. Also, dosing and administration differences in products may also be assumed with the naming system, which is why the suffix will be helpful in those situations. I also believe that with this naming system, they need to differentiate the products in the computer order systems and be able to have adverse event reporting that distinctly identifies them, which the naming system will with the current suffix system.

Brandon Shank, PharmD, MPH, BCOP, Clinical Pharamcy Specialist, discusses the merits of the current biosimilar naming system.

Dr Brandon Shank: Biosimilar Naming and Suffixes

What would be the impact of biosimilars on Part D drug pricing? 

So right now, our country is facing a drug price explosion. There’s been a couple of areas where it’s growing fastest—the hematological space, where we’re growing about 12.9% per year in terms of cost, and in the oncologic space, [which is] growing at 4.9%. So, we don’t have infinite resources, and at some stage, the system with either implode, or we have to look at drug pricing. Biosimilars do have a role. They can help in reducing some of the additional escalation of the expenses. When we go back and look at the European experience, in Europe, in 10 years’ time, drug prices have dropped by about 30% compared to the reference product. So clearly biosimilars do have a significant role that they can play in the Part D drug pricing space, and they also improve access as well, so biosimilars have a very valid and legitimate space in becoming part of the solution for Part D prices.

Kashyap Patel, MD, Medical Oncologist, Carolina Blood and Cancer Care, discusses the potential impact of biosimilar drugs on Medicare Part D drug pricing. 

Dr Kashyap Patel: Biosimilars and Medicare Part D Drug Pricing

Do you have concerns about automatic substitution of biosimilars for reference products? 

Yes, I do and I guess I don’t, to some degree. I do have [concerns with] automatic substitution, but it depends on who is doing the substitution and what is being substituted. If I place someone on a new medication and instead of getting the bio-originator product, I get a biosimilar as my first medication, right now I have no qualms about that. The patient is starting on a new medication, it is what it is, and we will see how they respond. However, if they are already on a bio-originator product and they are switched over, I have some concerns about switching a patient who is doing well. The third avenue where you could see switching, which I would be very opposed to, would be someone who is on medication—we’ll say etanercept&mdash;and the insurance company or the payer decides that adalimumab biosimilar is the medication of choice. Switching a patient from one drug, not only to a biosimilar, but to a biosimilar of another medication, has huge implications and is very concerning for me. As a rheumatologist, the problem with rheumatoid arthritis is that early on, we have joint damage, and if you lose control of the disease activity, in the long run you can see worse outcomes with increasing rates of disability, etc.

Marcus H. Snow, MD, Assistant Professor Rheumatology, University of Nebraska, discusses concerns about automatic substitution of biosimilars for reference products. 

Interviews