The Top 5 Biosimilar Articles for the Week of March 25

 A real-world study surveying physicians and patients on adalimumab biosimilar ABP 501 (Amgevita) in inflammatory bowel disease (IBD) found both patients initiating 

 and those who had switched from the reference product had higher satisfaction levels.

Sarfaraz K. Niazi, PhD, explains how the new 

 under the Medicines and Healthcare Products Regulatory Agency (MHRA) could expand biosimilar access within the United Kingdom, in his latest column.

Senators Michael Bennet (D-Colorado) and John Cornyn (R-Texas) have reintroduced the 

Increasing Access to Biosimilars Act to Congress

 is to boost competition and increase incentives for providers to prescribe biosimilars over their more expensive reference agents.

 presented at the American Academy of Dermatology (AAD) annual meeting examined the effects of switching from reference ustekinumab and adalimumab to biosimilar versions in patients with different types of psoriasis.

 7% overall last year, including a 15% spike in biosimilar sales, according to the company’s 

 for the fourth quarter (Q4) and full year (FY) 2023.

To read all of these articles and more, visit 

Videos

Here are the top 5 biosimilar articles for the week of March 25, 2024. 

Ha Kung Wong, JD on antitrust lawsuits

In an interview with The Center for Biosimilars

, intellectual property lawyer, Ha Kung Wong, JD, partnered with 

, discusses the impact of lawsuits on biosimilar accessibility. He mentions a recent lawsuit by Johnson & Johnson (J&J), aiming to delay biosimilar competition and other relevant legal cases.

Wong points out that antitrust suits targeting biosimilar competition are not uncommon, especially for expensive drugs. He then elaborates on 3 past lawsuits: J&J’s antitrust suit regarding Remicade (reference infliximab), the Remicade exclusionary contracting lawsuit by Pfizer, and the lawsuit regarding Humira (reference adalimumab).

While these lawsuits might have discouraged the use of exclusionary contracts, their effectiveness remains debatable due to relatively small settlements compared to the drugs' revenue. The interview concludes surrounding the uncertainty of future lawsuits' and the impact they have on biosimilar accessibility.

Recently, CareFirst BlueCross BlueShield filed a lawsuit against J&J alleging that the company is “scheming” to delay ustekinumab biosimilar competition. How do you expect this case to play out and what impact could it have on the overall biosimilar industry?

This is not the first antitrust suit to be filed related to a biosimilar and biosimilar competition, particularly on drugs that are costly so it really isn't surprising to see another antitrust suit.

As a side note, talking about antitrust always reminds me of the 2001 movie 

 starring Ryan Phillippe and Rachael Leigh Cook, but I digress.

Previous antitrust suits, you know that I think we want to think about in conjunction with this one would be the 

Remicade exclusionary contracting class action lawsuit

. That actually was settled by consumers, third party payers for $25 million.

Remicade exclusionary contracting lawsuit by Inflectra

 biosimilar manufacturer, Pfizer. There was an undisclosed settlement agreement there.

, which found that filing numerous patent applications was a form of petitioning the government, qualified for Noerr-Pennington immunity and that protects the filing under the First Amendment petition and free speech clause.

Even if the petition is anticompetitive, it's immune from antitrust action. I bring those up because so far, the biosimilar antitrust suits may have had some positive impact on decreasing the usage of exclusionary contracts to prevent biosimilar formulary coverage.

However, it's yet to be seen maybe debatable how steep of a deterrent something like a $25 million settlement is on a drug similar to Remicade, which is making over $6 billion a year.

It’s unclear whether another antitrust lawsuit will have a significant impact on biosimilars going forward or not. But certainly something that we should keep an eye on and certainly something we should be vigilant about.

Ha Kung Wong, JD, an intellectual property attorney, discusses lawsuits by drug companies aimed at delaying competition from biosimilars, but the effectiveness of these lawsuits in hindering biosimilar access remains uncertain.

Antitrust Lawsuits on Increasing Biosimilar Accessibility

The Top 5 Biosimilar Articles for the Week of March 18, 2024. 

 from Association of Cancer Care Centers 50th Annual Meeting and Cancer Center Business Summit (AMCCBS) and the American Academy of Dermatology (AAD) highlight the benefits of incorporating biosimilars into electronic medical records and the biggest barriers for home injection of biologics.

 A review looking back at the last 15 years of experience with the 

 (Zarxio) provides a detailed overview on how filgrastim biosimilars came to be and the evidence behind why oncologists have come to accept them as standard practice.

 In its earnings report for the fourth quarter and full year of 2023, 

 detailed its rising revenue growth, which it partly attributed to increased sales for its pegfilgrastim and ranibizumab biosimilars.

 Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care, a member of the Community Oncology Alliance, and member of The Center for Biosimilars® Advisory Board, glances back at the development of the 

 was reported to be as safe and effective as the reference product in a review of randomized controlled trials and real-world studies on immune-mediated inflammatory diseases.

Here are the top 5 biosimilar articles for the week of March 18, 2024. 

The Top 5 Biosimilar Articles for the Week of March 18

The Top 5 Biosimilar Articles for the Week of March 11, 2024. 

 analyzing 3 years of treatment patterns for patients with Crohn disease on biologics found that while more patients received infliximab, adalimumab, and vedolizumab initially, ustekinumab showed the highest persistence and lowest dose escalation rate, indicating potentially better clinical response compared to other biologics.

provided updates on how provider acceptance growth, evolving payer dynamics, and the growing pipeline for biosimilars will shape the biosimilar landscape over the next 5 years.

 (Tyenne; tocilizumab-aazg), making it the second tocilizumab biosimilar overall and first tocilizumab biosimilar to be approved with both intravenous and subcutaneous administration options.

Sarfaraz K. Niazi, PhD, takes a look at the 

European Medicines Agency's (EMA) announcement

 that it will investigate whether comparative efficacy tests should be needed for a biosimilar to receive regulatory approval.

 (denosumab-bddz; GP2411), the first biosimilar to reference Xgeva/Prolia (denosumab) in the US.1 The drugs will be used to treat osteoporosis and hypercalcemia as well as prevent skeletal-related events associated with bone metastases from solid tumors.

Here are the top 5 biosimilar articles for the week of March 11, 2024. 

The Top 5 Biosimilar Articles for the Week of March 11

Biosimilars Versus Bad Patents: Accessibility, Key Court Cases With Ha Kung Wong, J.D.

Ha Kung Wong, JD, an intellectual property attorney specializing in intellectual property law partnered with 

, discusses the patent system and biosimilar accessibility in an interview with The Center for Biosimilars

. He acknowledges concerns regarding "bad patents" that could limit access to biosimilars but expresses confidence that the FDA and 

 [United States Patent and Trademark Office] will refine the system to only grant good patents.

Wong highlights specific court cases involving biosimilars, including 

. He advises stakeholders to follow these cases as they may have a significant impact on the biosimilar market. Despite the challenges of bad patents, Wong assures us that biosimilars are continuing to enter the market and driving down health care costs.

How does the patent system impact biosimilar accessibility and how can it be improved to better balance investor interests and the need for more affordable health care options?

By and large, the patent system is really no different with respect to biosimilar accessibility, as it is to small molecule accessibility or any other areas of life sciences.

As outlined in the Constitution, good patents help protect innovation, which in turn provides incentive for development of new life saving treatments, as well as disclosure of information to promote continued development of those treatments. The problem we have is that not all patents are good, right? There are bad patents and they can be impactful in terms of limiting health care options.

The FDA and the USPTO [United States Patent and Trademark Office] have been collaborating to provide a more robust patent system for pharmaceutical patents and more robust in terms of making sure good patents come out and not bad patents.

For instance, they propose more training and time for patent examiner's during prosecution, better examination means better patents, and they have encouraged increased disclosure of regulatory materials during prosecution.

This proposal could help to avoid patents being issued that should not be either based on not properly meeting the patentability requirements or by inappropriately overlapping with earlier issued patents, which could in turn lower the number of bad patents that biosimilars would have to contend with.

That being said, the patent system as is hasn't necessarily negatively impacted biosimilar accessibility. Biosimilars are getting to the market and are bringing prices down and providing more affordable health care, even when they don't necessarily capture large market shares.

According to the quarter for 2023 report by 

, the average sales price declined on average of 41% 3 years post-biosimilar launch and over 50% in the oncology space. There's a lot of benefit here from biosimilar launches and patents aren't necessarily stopping that from happening but we should be vigilant about bad patents. We don't want those to be allowed.

We’re starting to see some of the settlements for patent cases involving ustekinumab biosimilars as well as new cases regarding aflibercept biosimilars. What other biosimilar court cases should stakeholders be watching?

Well, there are a number of them and keep in mind that a lot of these biosimilars cases are fact specific so they won't necessarily result in something that will have wide ranging impact on the industry. But I do think there are a couple that we should keep an eye on.

First of all, Eylea has 5 pending lawsuits, a number of pending 

aBLAs [abbreviated Biologics License Applications

]. This is definitely going to be a drug to watch in terms of decisions and market impact.

Solaris, they had a first litigation related to the proposed Solaris biosimilar, SB12, which was just filed on January 3 of this year by 

 and again Samsung Bioepis. Samsung Bioepis provided its 180 day notice of commercial marketing over 6 months ago in July of 2023, which means it could launch at risk at any point after receiving FDA approval. It was a pending aBLA that was accepted by the FDA by July of 2023 so it's possible that launch could be soon if Alexion doesn't request supplementary injunction.

There's a lot of things here, a lot of moving parts here that we want to keep an eye on to see how that impacts the process when which a biosimilar might go through if they want to be aggressive and launch at risk. There's Tysabri, which has an ongoing litigation related to that 

 product, Tysabri, and there's a biosimilar 

, which was FDA approved in August [2023].

The preliminary junction was denied in June, Sandoz has expressed a plan to launch at risk in the first half of 2024. This would be the first biosimilar launch for Tysabri which was approved almost 20 years ago so certainly something to keep an eye on there as well.

Intellectual property attorney, Ha Kung Wong, JD, discusses concerns about "bad patents" hindering biosimilar access, but assures that the FDA and United States Patent and Trademark Office are working to improve the system.

Biosimilars vs Bad Patents: Accessibility, Key Court Cases With Ha Kung Wong

The Top 5 Biosimilar Articles for the Week of March 4

Congress of European Crohn’s and Colitis Organisation (ECCO)

, Celltrion and Samsung Bioepis presented new finding from their respective biosimilar analyses, demonstrating positive safety and efficacy measures for the biosimilars as treatments for Crohn disease (CD) and ulcerative colitis (UC).

 announcement that it will investigate whether comparative efficacy tests should be needed for a biosimilar to receive regulatory approval.

 Samsung Bioepis provided multiple updates on its biosimilar projects, including a 

 for its aflibercept biosimilar candidate as well as regulatory news in the European Union and Republic of Korea.

 After receiving 3 complete response letters, Alvotech has officially received 

US approval for its adalimumab biosimilar

 (AVT02; Simlandi), making it the first approval for the company, the 10th biosimilar to reference Humira, and the third interchangeable adalimumab biosimilar.

 primarily serve to uphold inflated list prices, typically prompted by loss of exclusivity, aiming to safeguard market share and counter biosimilar competition, although forthcoming legislative changes targeting high drug costs could lessen their significance moving forward.

Here are the top 5 biosimilar articles for the week of March 4, 2024.


The Top 5 Biosimilar Articles for the Week of February 26

The Revolution that Died on its Way to Dinner Table,

” reported in the New York Times on February 9, summed up the history of the gleaming vision of a world just beyond the present: a world in which a high-tech factory housing bioreactors will produce formed steaks, millions of pounds a day to feed the world at an affordable cost—

, Celltrion and Samsung Bioepis presented new finding from their respective biosimilar analyses, demonstrating 

Crohn disease (CD) and ulcerative colitis (UC)

 (VA) has chosen to replace Humira (adalimumab) with Organon’s biosimilar version on its national formulary; Biocon Biologics and Sandoz announce a new partnership in Australia for 2 biosimilars; Alvotech settles with Johnson & Johnson over its biosimilar to Stelara (ustekinumab) for the European and Canadian markets.

After receiving several complete response letters (CRLs), Alvotech has officially received 

FDA approval for its adalimumab biosimilar

 (AVT02; Simlandi), making it the first US approval for the company and tenth biosimilar referencing Humira (adalimumab). The product was also approved as an interchangeable biosimilar.

Here are the top 5 articles for the week of February 26, 2024.

Ha Kung Wong, JD 2

, brings a wealth of experience to the field of intellectual property law, specializing in patent and trade secret litigation. Beyond courtroom battles, his expertise extends to negotiating complex agreements for mergers, acquisitions, and collaborations across diverse industries, including pharmaceuticals, biologics, and cutting-edge fields like digital health and artificial intelligence. Wong's client roster boasts renowned names like Alkermes, Allergan, and the Bill & Melinda Gates Foundation.

 delved into Wong's insights in an interview on proposed patent law changes poised to significantly impact the biosimilars sector. These changes encompass limitations on asserted patents, the potential elimination of interchangeability requirements, and increased scrutiny of pharmacy benefit managers (PBMs).

Do you foresee any potential shifts or reforms in patent law that could positively or negatively impact the biosimilars sector in the near future?

Predicting whether there will be statutory shifts or reform in patent law is like trying to predict what will happen in the next 

 movie—you have no idea what specifically is going to happen but it's probably going to have some explosions that ultimately, will not be applicable to the real world. That being said, there are a few things I think that we might want to keep an eye on. I say "very few" only because we've seen a lot of things introduced and not a lot of follow through. There's a lot of good intentions out there, but there's not a lot of follow through. That being said, here it is.

First of all, Senators [Peter] Welch [D, Vermont], [Mike] Braun [R, Indiana], and [Amy] Klobuchar [D, Minnesota] introduced legislation in the Senate, and Representative [Jodey] Arrington [R, Texas] in the House on January 2024 that would limit the number of patents that could be asserted in a patent litigation. If this were to proceed, this may or may not have a practical effect because we've seen that most Bundled Payments for Care Improvement 

lawsuits that have been asserted are asserted on 10 or less patents. So, having an artificial limit may not make it any better. But it might. Who knows? It is certainly something to keep an eye on.

The Biosimilar Red Tape Elimination Act was introduced in July 2023 by Senators [Mike] Lee [R, Utah], [Ben Ray] Lujân [D, New Mexico], Braun, and [J.D.] Vance [R, Ohio]. That bill would eliminate the 2 separate designations of biosimilars and interchangables, which we know, exist in the US and we are the only country that does that. Every other country in the world only has 1 level of biosimilarity. It's possible if the interchangability requirement was removed, there could be greater uptake of biosimilars due to the possibility of automatic substitution at the pharmacy level, like we see with generic drugs. There may be increased confidence in biosimilars because they would be seen as perhaps closer to the reference product.

The problem is that when people hear there's a "biosimilar" but there's a higher level called "interchangable", their automatic reaction is, "Well that means biosimilars are garbage, why would I want that? I want an interchangeable. Oh, there's no interchangable? Then I don't want that product."

I think it will help with consumer confidence, patient confidence, and will help with health care provider confidence because a lot of doctors just don't know the difference. 

In June 2023, Senators [Thom] Tillis [R, North Carolina] and [Chris] Coons [D, Delaware] reintroduced the Patent Eligibility and Restoration Act of 2023 to reform patentability requirements under Section 101. There, the bill seeks to clarify which inventions are eligible for patenting in the US. If that bill were to be passed, it would overturn Supreme Court decisions in Mayo, Alice, and Myriad, which we've all been talking about for 10 years. It would be really interesting to see how that would impact the pharmaceutical and biologics industry in particular.

Finally, there's been this increased congressional scrutiny of pharmacy benefit managers or PBMs. Congress has launched various investigations into PBM practices and while this isn't directly related to patent law reform, it could have a significant impact on biosimilar uptake given the preferential formulary coverage of biosimilars and how that plays a big role in whether biosimilars are used and whether cost savings are realized or not.

I've been on record saying this for a long time now. PBMs are middlemen that don't need to really be there, but at the end of the day, they end up increasing the cost for patients and it would be interesting to see if all this congressional scrutiny will lead to better cost savings for patients.

Ha Kung Wong, JD, examines proposed patent law changes that could significantly impact the biosimilars sector, including limitations on asserted patents, elimination of interchangeability requirements, and heightened oversight of pharmacy benefit managers.



Patent Shift Predictions, Legal Landscapes of Biosimilars With Ha Kung Wong

The Top 5 Biosimilar Articles for the Week of February 19, 2024.

 In its market sustainability for infused 

, IQVIA echoed the need to address issues regarding misaligned incentives regarding rebates, slow or limited uptake, and concerns about market viability, which will be crucial for ensuring the long-term sustainability of biosimilars and maximizing their benefits for the health care system.

 After a patient with multiple sclerosis (MS) was forced to pay exorbitant out-of-pocket costs for a brand name medication when she could’ve gotten a generic for way less, the patient filed a class action complaint against her employer, Johnson & Johnson (J&J), for violating the 

 that 3 of its oncology biosimilar products have won tender contracts in France and Italy, and an experimental oral delivery device utilizing an ustekinumab biosimilar was successful in a phase 1 study.

efficacy, safety, pharmacokinetics, and immunogenicity

 were found when comparing Stelara, originator ustekinumab, and CT-P43, an ustekinumab biosimilar candidate, in patients with moderate to severe plaque psoriasis.

 assessing several disease states found no significant differences in serious adverse events, deaths, or treatment discontinuations between patients who switched from reference products to biosimilars and those who did not.

Here are the top 5 biosimilar articles for the week of February 19, 2024.

The Top 5 Biosimilar Articles for the Week of February 19

The Top 5 Biosimilar Articles for the Week of February 12

 is just as effective as the originator drug (Enbrel) in treating Australian patients with rheumatoid arthritis (RA), leading to significant cost savings.

 showcased the success of biosimilars while also emphasizing the impact of inflation on different drug classes, particularly in oncology and immunology.

Since January 31, 2023, the United States has seen a boom in the adalimumab market. With 

 launching throughout the year, the US rheumatology, immunology, dermatology, and gastroenterology treatment spaces have a wealth of newer and cheaper alternatives to Humira (reference adalimumab).

In his latest column, Sarfaraz K. Niazi, PhD, highlights challenges in biosimilar development, emphasizing the 

 (USP) and advocating for collaboration and standardized guidelines to expedite cost-effective development without compromising safety or efficacy.

Here are the top 5 biosimilar articles for the week of February 12, 2024. 