The Center for Biosimilars Staff

global biosimilars week webinar

 was hosted by The Center for Biosimilars

 in partnership with the International Generics and Biosimilars Association.

Global Biosimilars Week (GBW) 2024 is an annual campaign designed to raise global awareness about biosimilar medicines and their role in improving patient care and access to affordable treatment options.

This year’s theme, "Advancing Access to Biosimilars," focuses on the progress made over the past two decades surrounding approval, market acceptance and adoption of biosimilars—as well as the challenges that remain in expanding access worldwide. With an effort to highlight the importance of collaboration among health care professionals, patients, stakeholders, and policymakers, the webinar will focus on 

 to advance access to biosimilars and will feature expert discussions on the key barriers to biosimilar uptake in different regions and explore strategies to overcoming these obstacles.



Current global trends in streamlining biosimilar regulatory requirements to foster efficient adoption and market growth.

Strategies to address challenges and improve biosimilar access.

The role of biosimilars in promoting health care sustainability and better patient outcomes.

, assistant managing editor of The Center for Biosimilars (host)

, senior vice president of sciences and regulatory affairs, Association for Accessible Medicines (moderator)

, PhD, Executive Director for Products Evaluation and Standards Setting, Saudi Food and Drug Authority

, PhD, scientist, technical standards and specification unit group lead, norms and standards for biologicals, Health Product Policy and Standards/Medicines and Health Products/World Health Organization 

enior quality specialist, European Medicines Agency

, director, Office of Therapeutic Biologics and Biosimilars Office of New Drugs, Center for Drug Evaluation and Research, FDA

Videos

This webinar celebrating Global Biosimilars Week was hosted by The Center for Biosimilars® in partnership with the International Generics and Biosimilars Association.

Webinar: Streamlining the Regulatory Process to Advance Access to Biosimilars

A. It lists approved biosimilars and their interchangeable status 

B. It provides information on biosimilar pricing and reimbursement 

C. It contains guidelines for biosimilar clinical trials 

D. It determines the manufacturing standards for biosimilars

A. It emphasizes the importance of clinical trials over analytical data

B. It requires biosimilars to demonstrate identical efficacy to reference products

C. It allows the FDA to consider a range of data sources to establish biosimilarity

D. It only considers data from post-marketing surveillance studies

A. By requiring annual clinical trials for all approved biosimilars

B. By monitoring adverse events through the FDA Adverse Event Reporting System (FAERS)

C. By allowing biosimilar manufacturers to self-report safety data

D. By conducting randomized controlled trials for every approved biosimilar

A. To fund biosimilar research and development

B. To expedite the review process for biosimilar applications

C. To cover the costs of post-marketing surveillance activities

D. To discourage the development of biosimilars by imposing financial burdens

A. By using a random alphanumeric sequence

B. By incorporating the manufacturer's name into the suffix

C. By considering the mechanism of action of the biosimilar

D. By consulting with patient advocacy groups

A. It provides financial incentives for biosimilar developers

B. It requires biosimilar developers to conduct additional clinical trials

C. It evaluates biosimilar manufacturing facilities for compliance with FDA standards

D. It offers regulatory guidance and support to expedite biosimilar development

A. By requiring biosimilar manufacturers to use the same raw materials as the reference product

B. By outsourcing biosimilar manufacturing to third-party contractors

C. By conducting regular inspections of biosimilar manufacturing facilities

D. By relying solely on analytical data provided by biosimilar manufacturers

A. Biosimilar extrapolation is based solely on analytical data

B. Biosimilar extrapolation allows for approval in indications not studied in clinical trials

C. Biosimilar extrapolation is only applicable to interchangeable biosimilars

D. Biosimilar extrapolation requires additional safety and efficacy studies in each new indication

A. It accelerates biosimilar approval by bypassing certain regulatory requirements

B. It delays biosimilar approval by requiring additional data submissions

C. It standardizes biosimilar approval timelines across all regulatory agencies

D. It streamlines the approval process for biosimilars with robust clinical data

Articles

Dive into biosimilar regulations in the US! Test your knowledge with our quiz on FDA rules, naming tricks, postmarket safety, and more. Ready for the challenge?

Quiz: The US Biosimilar Regulatory System

B) Limited clinical experience with biosimilars

C) Lack of confidence in the safety and efficacy of biosimilars

D) Concerns about differences or variances in manufacturing between biosimilars and their reference products

A) Implementing mandatory biosimilar substitution policies

B) Providing financial incentives to health care providers for prescribing biosimilars

C) Increasing patient co-payments for reference biologics

D) Restricting access to reference biologics in favor of biosimilars

A) Cough, cold, and flu vaccines will have a projected growth of 5% through 2028

B) Specialty medicines will represent about 43% of global spending in 2028; expected to constitute 55% of total spending in leading markets

C) The immunology space will experience fast growth in the range of 30% to 50%, in part due to adalimumab biosimilar entrants in the US

D) The diabetes space projected to reach 78% lower than invoice by 2028, driven by insulin price caps from the US Inflation Reduction Act, payer negotiations, and increased market competition

Have you been keeping up with the latest market trends? Take this quiz to find out how well you know the global biosimilars market.

Quiz: Biosimilar Market Dynamics and Trends

A) A contract the allows for a biosimilar to be covered under a country's health plan

B) A marketing strategy for promoting biosimilar awareness

C) A regulatory label allowing for biosimilars to be switched with their reference agents easily

A) NMPA (National Medical Products Administration)

B) CFDA (China Food and Drug Administration)

C) MHRA (Medicines and Healthcare products Regulatory Agency)

Explore the dynamic world of global biosimilar markets and policies! What do you know about the international biosimilar industry?

Quiz: The Global Biosimilar Landscape

B) International Conference on Harmonisation (ICH)

C) Pharmaceutical Inspection Co-operation Scheme (PIC/S)

D) Organisation for Economic Co-operation and Development (OECD)

A) Demonstrating complete structural identity to the reference product

B) Providing evidence from multiple studies to establish biosimilarity

C) Focusing on the most critical quality attributes of a biosimilar

D) Emphasizing clinical trial data over analytical and preclinical data

B) Complexity of the manufacturing process

A) Providing funding for biosimilar research and development

B) Facilitating faster approval timelines for biosimilars

C) Establishing pricing guidelines for biosimilars

D) Restricting the number of biosimilars entering the market

A) To differentiate between biosimilars and small-molecule generics

B) To create confusion in the market and discourage biosimilar use

C) To emphasize the clinical superiority of biosimilars over reference products

D) To distinguish biosimilars from their reference products and each other

A) Demonstrating clinical superiority over reference products

B) Evaluating the cost-effectiveness and economic impact of biosimilars

C) Establishing the interchangeability of biosimilars

D) Assessing patient preferences for biosimilars

A) Changing from an originator biologic to a biosimilar version or transitioning between biosimilars referencing the same originator

B) Switching between different biosimilars for the same indication

C) Switching from biosimilars to small-molecule generics

D) Avoiding the use of biosimilars in certain patient populations

Test your knowledge of major biosimilar policies, including challenging regulatory frameworks from around the world.

Quiz: How Well Do You Know These Biosimilar Policy Essentials?

B) A biologic drug highly similar to an already approved reference product

C) A brand-new type of biologic drug with unique characteristics

D) A generic version of a small-molecule drug

A) The Department of Health and Human Services (HHS)

B) The Food and Drug Administration (FDA)

C) The Centers for Medicare & Medicaid Services (CMS)

D) The National Institute for Health (NIH)

A) To demonstrate clinical superiority over reference products

B) To establish interchangeability between biosimilars and reference products

C) To show structural and functional similarity to the reference product

D) To prove that biosimilars are entirely distinct from the reference product

A) The process of extending the patent protection for an originator biologic drug

B) The approval of a biosimilar for additional indications not directly studied in clinical trials

C) The restriction of biosimilar use to specific patient populations

D) The assessment of biosimilars only for the indications studied in clinical trials

A) Achieving a completely different therapeutic effect than the reference product

B) Creating a biologic drug with the same structure as the reference product

C) Demonstrating clinical superiority over the reference product

D) Providing a more affordable alternative to the reference product

A) The first biosimilar developed in a specific therapeutic class

B) The original biologic drug that a biosimilar is compared to for approval

D) A non-biologic drug used as a reference for biosimilar development

A) To restrict the use of biosimilars to specific patient populations

B) To allow biosimilars to be substituted for the reference product without consultation

C) To limit the number of indications for which biosimilars can be approved

D) To increase the exclusivity period for originator biologic drugs

A) Encouraging the use of biosimilars without monitoring adverse effects

B) Monitoring and ensuring the safety of biosimilars post-approval

C) Assessing the cost-effectiveness of biosimilars in comparison to originator products

D) Restricting the availability of biosimilars in the market

A) A policy for biosimilars within the Affordable Care Act

B) The policy that created a regulatory pathway for the approval of biosimilars in the United States.

C) A framework for resolving patent disputes between biosimilar sponsors and reference product manufacturers

D) The policy that introduced the concept of "biosimilar" and "interchangeable" products

Intro to Biosimilars is now in session! Test yourself on how well you know these biosimilar basics.

Quiz: The Basics of Biosimilars

Here are the top 5 biosimilar articles for the week of November 6, 2023.


 found that providers agree that use of biosimilars in inflammatory bowel disease (IBD) is safe and effective in both patients who are treatment-naïve and those who are already being treated with a reference agent.


 for its denosumab biosimilar candidate; the Community Oncology Alliance (COA) forms the Drug Policy and Regulation Committee; the International Generic and Biosimilar Association (IGBA) and the World Health Organization (WHO) collaborate on a new initiative.


Number 3: On this Biosimilars Roundup episode, we discuss the 

, including 3 regulatory approvals, 2 complete response letters, and new data and industry insights that have the potential to impact the entire US biosimilar industry.


 to improve clinical trials, including a provision to possibly eliminate clinical efficacy testing for biologic products, which evidence has suggested may not be necessary, according to Sarfaraz K. Niazi, PhD.


 (ustekinumab-auub), making it the first approval for a biosimilar referencing blockbuster drug Stelara (ustekinumab). The agency also granted Wezlana an interchangeability designation.


To read all of these articles and more, visit 

The Top 5 Biosimilar Articles for the Week of November 6

Geoff Biegler, JD, a principal at Fish & Richardson

In an interview with The Center for Biosimilars

, Geoff Biegler, JD, a principal at Fish & Richardson, an intellectual property law firm, expands on his presentation on 

biosimilar legal challenges throughout 2022

, providing insight on the inner workings of the patent dance and how a Supreme Court decision could impact future cases.

You noted that the number of new Biologics Price Competition and Innovation Act (BPCIA) filings in 2022 was significantly lower than the peak of filing during 2018 but was an increase from 2021. Do you think 2023 is in store for even more filings than 2022, and do you think we may return to 2018 levels, especially as big products, like Stelara (ustekinumab), Simponi (golimumab), and Prolia (denousmab) are approaching their market exclusivity expiration dates?

Obviously, none of us has a crystal ball to know what's going to happen, but if we're reading the tea leaves, it seems likely are going to see an increase in the number of cases next year and then potentially going forward. And I think the starting point for that is we did see an increase in the number of biosimilar applications. Last year, it was up to 11, which was more consistent with what we saw in 2018 and 2019, prior to the COVID-19 pandemic. And that, of course, is basically the prerequisite for lawsuits in this area. Without biosimilar applications, you don't have a lawsuit. So, that sort of points up.

We’ve also seen a number of big players in this space, like Teva Pharmaceuticals and Sandoz, signaling that they are working on a pretty hefty number of new biosimilars. I think they both were in the teens in what projects they've announced they're working on. So, I'd expect we're going to see more applications in the next few years. I think those numbers of applications will continue to go up, and then resulting litigation is likely.

In the longer term, you're right. We walked through in the webinar some of the molecules that are going to start to lose exclusivity in the next decade. There's a number of big money producing molecules in there, in addition to the few that you mentioned. For example, Keytruda (pembrolizumab), which I think is the biggest selling drug in the world right now, is going to be a challenge later this decade. So, there's a number of new molecules that have the potential to fuel more applications and resulting litigation.

The last thing is that could factor into this—that'll be really interesting to watch—is the Humira (adalimumab) market. We talked in the webinar about the number of biosimilars for Humira that are going to launch this year. And it's really the first drug for which we have this high of a quantity of biosimilars launching in a similar timeframe, and there's an interchangeable Humira biosimilar that's going to be included in that. So, I think that has the potential to affect the market dynamics. 

On the one hand, if Humira maintains market share in the face of all that competition that might change the calculus a little bit for people who are looking at biosimilars of other molecules. And on the flip side, if there's really good adalimumab biosimilar uptake, it might sort of help the business case for some biosimilar manufacturers for future biosimilars. So, I think that's going to be something that'll be interesting to watch and see what the impact of that is.

When discussing the 4 main patent litigations that occurred in 2022, you described some parties as going through “some steps of the patent dance” and others as going through “the full patent dance.” What do you mean by this phrasing, and can you shed some light into the inner workings of these kinds of lawsuits cases?

So, I've got to give you a little bit of context here to make sure that this makes sense, because the statutory schema is pretty complicated here. The 

 is a series of exchanges between the biosimilar applicant and the reference product sponsor. It generally starts when the biosimilar applicant files its biosimilar application. Like with the Hatch-Waxman Act, the actual filing of that application is an artificial act of infringement. So, theoretically, the reference product sponsor can sue for patent infringement based on that.

But the statute here prevents the reference product sponsor from filing suit right away, until the reference product sponsor sees if the biosimilar applicant is going to engage in this patent dance the from the statute. And if the biosimilar applicant chooses to engage in the patent dance, it starts with the biosimilar applicant sending the reference product sponsor a copy of its biosimilar application, and then it proceeds.

The next step is the reference product sponsor provides a list of patents that it might assert against this biosimilar product. The biosimilar applicant comes back and provides contentions on noninfringement and invalidity for those patents. The reference product sponsor comes back with responsive contentions on those issues. And then the idea is that the parties negotiate the list of patents down to what will be asserted in the first wave of litigation.

So, those are all the steps if you go through the full dance. But the Supreme Court has told us that that's all optional on the part of the biosimilar applicants. So, the biosimilar applicant can do all of that, some of that, or none of that and not even provide their biosimilar application. The effect of that is if the biosimilar applicant either doesn't dance at all or somewhere through the process decides it doesn't want to participate anymore, the ability to control the scope of the litigation as far as what patents, the number of patents, and the timing of the litigation reverts to the reference product sponsor, who then can file suit with much less limitations.

With that kind of backdrop, what we saw this year was 1 party that went through all the steps of the dance; that was in the Biogen vs Sandoz case. We saw another case where the biosimilar applicant provided its application, got the list of patents from the reference product sponsor, and then basically bowed out at that point. And then, we saw a third case, Janssen vs Amgen, where Amgen declined to give Janssen its biosimilar application, which just allowed Janssen to sue on whatever it wanted to. So, we're seeing various approaches.

As far as the inner workings, there's just a lot of strategic considerations here. From the perspective of the biosimilar, who is controlling a lot of these decisions as to what to participate in. There's a balancing act and considerations between getting certainty as to the scope of the patents that could be asserted and potentially limiting the remedies that the reference product sponsor can obtain on those patents vs as a biosimilar applicant, you are giving a lot of information very early in the process.

You could be giving them application details of your manufacturing process or your contentions on the other party's patents. These are things that in normal litigation, even in Hatch-Waxman litigation, you don't typically provide until after lawsuits have been filed and you're well into the case. So, you're giving a lot of information early that you normally would not. So, I think depending on the size of the portfolio, whether there are key patents that the biosimilar applicant thinks need to be cleared and might resolve the dispute more broadly and other considerations, there's a lot of strategy that goes into deciding whether to dance and how far in the dance to proceed.

You also mentioned during the webinar that the majority of BPCIA cases have been filed in Delaware courts. Why is this?

You see that with a lot of patent litigation generally, but the main reason is because so many companies are incorporated in Delaware. And there's a guarantee that you can sue a company in its state of incorporation. There's been a lot of developments in venue law over the last 5 to 10 years, which basically establishes where can I sue somebody and if they don't have a presence there, is it fair that I can sue them. Delaware is one place where if companies are incorporated there, you can definitely sue them there. So, that's one reason.

The second reason is one of familiarity. The Delaware courts just have a long history of litigating patent disputes and hearing Hatch-Waxman cases and now biosimilar cases. And so I think there's a familiarity with the judges there and I think a lot of litigants feel like the judges there are a little bit more of a known quantity than perhaps judges in other districts who don't hear as many of these cases and may not have as much experience with them.

During the webinar, you brought up the Supreme Court’s preparation to weigh in on the Amgen vs Sanofi case regarding a PCSK9 antibody, saying that while it isn’t a BPCIA case, it could have implications for biosimilars. How might this decision impact biosimilars, and why should the industry keep its eye on it?

So, this decision has the potential to impact patent law generally, significantly, depending on how it turns out. This is the first case on the 

 that the Supreme Court has taken, at least in the modern era. And the question the Supreme Court has taken up here relates to the full scope of the invention and whether that has to be enabled, and if so, what the standard is to show that. And this has the potential to change how we view the enablement defense, generally, but it's been particularly relevant in the biotech area over the last decade as well as a related defense called written description.

The case itself is actually about biologics. It's about Amgen's Repatha (evolocumab) and Sanofi's Praluent (alirocumab). They're both antibodies, and they both target the same antigen in the body, which is PCSK9. And the story is that Amgen made certain antibodies that bound to this PCSK9, including Repatha, but they effectively claimed all antibodies that bind to PCSK9, and that would encompass Praluent, even though I think there's no dispute that Amgen never actually made that exact antibody.

Sanofi basically convinced the district court and then the Federal Circuit that Amgen had claimed too much or claimed too broadly, more than invented, and that it hadn't enabled sort of the "full scope of the claim." In other words, the patent might teach you how to make and use Repatha, but it didn't teach you how to make and use general antibodies that bind to this particular target. So, that was the holding below.

And now the Supreme Court is going to consider whether, in fact, the decision of the patent was not enabled or that didn't teach how to make antibodies generally that bind to this target.

So, this could have a huge impact in competitor biotech cases, where you often don't have the same antibody or protein that your competitor does, but you might be trying to target the same target in the body. That's basically what happened here. And when one company claims broadly and if those patent claims are okay, they often will go after competitors who are pursuing a drug to the same target even though it's a different drug.

In biosimilar cases, typically there's less ability to actually change the structure of the protein. Usually, you have to have the same one. But it has the potential to significantly impact how broadly reference product sponsors (RPSs) can claim inventions related to their product generally. So, this could carry over to, for instance, formulation patents, manufacturing patents, and a whole host of other patents and affect how broadly the RPSs are allowed to claim relative to exactly what it was that they made and disclosed in in their patent.

So, it's going to be really impactful in the entire patent world, depending on how it comes out. But I think particularly in biotech and in biosimilars litigation, it's going to be significant potentially.

In August 2022, an antitrust claim against AbbVie’s practices using patent litigation to postpone adalimumab biosimilar competition in the United States was dismissed. The case claimed that AbbVie was creating 

 to prevent competition from entering the market, but the court said AbbVie’s actions did not count as anticompetitive practices. What were the reasons for the court’s decision, and what implications could it have for future anticompetition claims?

There's a lot to unpack with this one. I'll try to keep it fairly brief. So, the plaintiffs here had basically argued that AbbVie violated antitrust laws by using what are called thickets of patents to block biosimilar competition. And in this case, AbbVie had over 130 patents that it said covered Humira that it could potentially assert against the biosimilar maker. So, what the plaintiff said was, "Look, the sheer number of patents here deterred biosimilar competition improperly." And within that large group of patents, a lot of them are really "weak." That's the way that they were characterized. 

So, the argument was, it wasn't just the fact of having the patents that was how AbbVie was preventing competition; it was the sheer size of their portfolio and their ability to get patents that were not particularly strong just to deter biosimilar competition. Just the sheer amount of work that the biosimilar manufacturers had to do to get past all these patents was the activity that was alleged to be anticompetitive.

The Seventh Circuit said, essentially, that they relied on the Noerr-Pennington doctrine, which protects companies from liability from antitrust litigation when the party petitions the government, which has been understood to mean also getting a patent and asserting a patent as long as it's not a sham litigation. What the Seventh Circuit said here basically was the number of patents doesn't matter. I think, as the Court said, "What's wrong with having a lot of patents?" The patent laws do not set a cap on the number of patents any one person can hold. So, the court was not moved by the argument that the sheer number could be anti-competitive.

The court also did not buy into the idea that it mattered if some of the patents were "weak." The court said, "Look, patents are either valid or invalid. They're broad or narrow. And there's not really any such thing as a weak patent. It's either valid or invalid, and it might be narrower if it's weaker. But in any event, the First Amendment protects AbbVie and others' rights to assert patents, weak or not weak." So, that was the basic structure of the opinion on patent thickets.

As to what it means going forward, I don't know that it's going to mark the end of arguments about patent thickets. What it seems to have done, unless another circuit goes in a different direction, is anyone who's going to raise a challenge like this is going to have to do more probably than point to sheer numbers, because that is really what the court was not buying—that the sheer number was a problem. The court basically said, "How do we know when we're at one too many? Where is the line? It's not something that we can actually determine." There might be more challenges to these large portfolios that some of these companies hold on their biologics, but the theory is going to probably have to change.

On the other piece, on the pay-for-delay, the scenario was that AbbVie had allowed particular biosimilar manufacturers earlier entry into the EU market, then into the US market, and the allegation was that letting them in the EU market was essentially a reverse payment, that AbbVie was giving biosimilar manufacturers something of value, that was getting into the EU market early, in exchange for delaying their entry into the US market. And the Seventh Circuit said, there's differences in patent laws between the 2 jurisdictions and that different dates could be a result of that. And basically, it was too speculative to say that this was some actual reverse payment, as opposed to just the result of a good faith or arm's length negotiation between the parties, where they ended up giving an earlier date in one jurisdiction than in another. 

So, on that piece, again, this is just 1 decision from 1 circuit, and other circuits can always go in a different direction. But the takeaway, at least in the Seventh Circuit, is that if parties simply agree to entry dates in different places, that's probably not going to be enough to constitute a payment. I think the court here seemed like it wanted to see a more concrete payment as the basis of a reverse payment claim, as opposed to just the party selecting entry dates in different places.

To view the full webinar on the Fish & Richardson website, 

Geoff Biegler, JD, a principal at Fish & Richardson, an intellectual property law firm, expands on his presentation on biosimilar legal challenges throughout 2022, providing insight on the inner workings of the patent dance and how a Supreme Court decision could have an impact on future cases. 

Q&A: Patent Attorney Provides Insight Into Biosimilar Legal Challenges

Kyung-Ah Kim, executive vice president of Samsung Bioepis

This written Q&A, featuring Kyung-Ah Kim, executive vice president of Samsung Bioepis, is part of a 3-part interview series expanding on the discussion from our LinkedIn Live event “

In Sight: The Future of Biosimilars in Ophthalmology Care

 cataloguing the FDA’s efforts to increase confidence in ophthalmology biosimilars. Part 3 will be a video interview about the initial market response to ophthalmology biosimilars and how industry leaders can work together to increase uptake.

What factors are companies looking at when deciding which markets are worthy of investing in to develop a biosimilar?

 We are applying more and more rigorous standards and setting a high bar when it comes to choosing the next therapeutic candidates.

Beyond our fundamentals, we assess the market size, which reflects the patients’ needs, the latest landscape of other biosimilar development status, and whether we will be the first market entrant.

As part of a series of interviews, Kyung-Ah Kim, executive vice president of Samsung Bioepis, offered insight into how developers view the current biosimilars market, the relevance of interchangeability, and the usefulness of clinical efficacy testing.