Ha Kung Wong, JD 1

, Ha Kung Wong, JD, is a lawyer practicing general intellectual property law, emphasizing patent and trade secret litigations. Wong negotiates for mergers, acquisitions, vendor agreements, and collaborations in pharmaceuticals, biologics, chemistry, medical devices, digital health, and artificial intelligence. He has represented Alkermes, Allergan, Alnylam, Materia, Shionogi, Stemline, UCB, and Bill & Melinda Gates Foundation and Gates MRI as clients.

This interview for the Center for Biosimilars

 focuses on Wong's perspective of the patent legal system, the importance of this process, and how it affects biosimilar development.

Can you explain the patent legal system biosimilars are required to undergo and why this process is important to their development?

Sure, so for biosimilars, there's the BPCIA or the Biologics Price Competition and Innovation Act of 2009, which is actually an optional framework of information exchanges between biosimilars and the reference product sponsor, or what we call the RPS, prior to filing an infringement lawsuit.

The BPCIA allows for 2 phases of litigation. One, following the biosimilars aBLA [abbreviated biologics license application] submission and the second phase triggered by the biosimilars notice of commercial marketing. Now, the idea is that the most important patents can be dealt with while the biosimilar application is under FDA review. That gives the possibility of resolving the lawsuit after only litigating a small subset of patents, instead of the RPS' entire portfolio. That can be quite large and sometimes in the hundreds.

So, to start this first phase exchange of materials, which is often referred to as the patent dance, the biosimilar notifies the RPS that the FDA has accepted its biosimilar application within 20 days of that acceptance and provides the RPS with its aBLA and "other manufacturing information".

That starts off this kind of exchange of information regarding the patents that might be infringed by the biosimilar and which they think might be likely to be licensed whether the biosimilar feels like there is an infringement, validity, or enforceability problem or not. Ultimately, what happens in the first round of litigation is that you narrow the number of patents that you actually litigate right away. If the parties can't agree, the BPCIA gives a provision for determining the list of patents that can be litigated in the first phase and the remainder gets litigated in the second phase.

For most BPCIA litigations that most parties have participated in at least some part of the dance and as I mentioned before, it was after the statute came out it was decided by the courts that this was optional.

A lot of people said, "Well, why would anybody go through this?" It turns out, it helps both sides, right? The biosimilar gets that chance to narrow it down to the patents that are most important so they're not expending an enormous amount of resources litigating hundreds of patents, and the RPS gets a chance to really zone in on the patents that are most important to them and try to protect them first, then try to seek licenses on those that can be some sort of settlement. So 24 of the litigations that have occurred, have completed this entire patent dance, 19 participated in some portion of it and didn't finish, but only 9 didn't participate.

You can see that even though it's optional, a lot of parties find some benefit to going through this process. Now, the interesting thing about it is that when it came out, I thought this is the most half-baked process ever.

That's still true, but it's better than nothing is what I think is happening. Most of the BPCIA litigations are actually ending in settlements. Thirty-one of 46, or 67%, of terminated BPCIA litigations ended in settlement or stipulated voluntary dismissals.

Very few cases have gotten the verdict, which is actually part of what we want. I think this statistic that I'm raising is demonstrating that the primary benefit of the BPCIA process is being met. That was to resolve any patent related disputes early, prior to impact on the market, thus allowing both parties to direct resources appropriately to their respective products and avoid the need to address potential damages.

In many ways, this is similar to what the Hatch-Waxman process was meant to address for small molecules. So far, it appears to be working for biologics and biosimilars, and really helping in development on both sides.

Videos

In an interview with Ha Kung Wong, JD, he addresses the patent legal system biosimilars are required to undergo and how this helps resolve patent disputes early in the development process. 

Navigating the Biosimilar Patent Landscape With Ha Kung Wong

The top 5 biosimilar articles for the week of February 5, 2024. 

 found that the introduction of biosimilar drugs significantly increased access to biologic therapies and Janus kinase (JAK) inhibitors for patients with rheumatic musculoskeletal diseases (RMDs), while also reducing treatment costs.

 greater biosimilar adoption than the English average after it implemented a new policy that prioritizes best-value biologics, including biosimilars, for new-start patients and those already treated with originators.

 (Cimerli) to Sandoz; Celltrion has completed its biologics license application filing for its tocilizumab biosimilar (CT-P47); Alvotech shares positive pharmacokinetic results for its denosumab biosimilar candidate.

 tend to be the most common type of patent referenced in litigation regarding biosimilar development, other patents actually have a greater impact on delays for biosimilar market launches.

Since January 31, 2023, the United States has seen a 

. With 9 adalimumab biosimilars 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).

To read all of these articles and more, visit 

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

The Top 5 Biosimilar Articles for the Week of February 5

The Top 5 Biosimilar Articles for the Week of January 29, 2024.

 biosimilars concluded that these biosimilars “can be used as safely as their respective reference biologics.”

, published on the JAMA Health Forum, found biosimilar use and market share higher in 

 compared with traditional Medicare (TM) plans for most biosimilar products, except for bevacizumab.

 The FDA, Congress, biologic developers, and associations dedicated to 

evaluating the US biopharmaceutical space

 will need to work together to overcome challenges to biosimilar accessibility, says Sarfaraz K. Niazi, PhD, in his new column.

 A Korean health agency issued Samsung Bioepis an administrative penalty related to its biosimilar referencing Eylea (aflibercept); the FDA updates its labeling recommendations for 

; Alvotech receives another Form 483 after the FDA reinspected its Iceland-based manufacturing facility.

 in the first 3 years after initial launch; however, uptake speed continues to differ between treatment spaces, according to Samsung Bioepis’ 

Here are the top 5 biosimilar articles for the week of January 29, 2024.

The Top 5 Biosimilar Articles for the Week of January 29

The Top 5 Biosimilar Articles for the Week of January 22, 2024.

 uptake patterns within different health insurance plans found that low-flexibility plans, such as health maintenance organizations and exclusive provider organizations, were more likely to initiate biosimilar therapies than more flexible plans.

 (Rixathon and Truxima) and the reference drug (Rituxan) exhibited similar safety and efficacy outcomes in patients with immune thrombocytopenia (ITP), an autoimmune disease followed by a low platelet count, according to a recent analysis.

 Coherus Biosciences’ on-body injector version of Udenyca (pegfilgrastim-cbqv), making it the first biosimilar to reference Neulasta Onpro, the pegfilgrastim product that holds the majority of the pegfilgrastim market share.

, the IQVIA Institute for Human Data Science predicted that losses for originator products will rise from $111 billion to $192 billion by the end of 2028, thanks to market introductions of 

Here are the top 5 biosimilar articles for the week of January 22, 2024. 

The Top 5 Biosimilar Articles for the Week of January 22

The Top 5 Biosimilar Articles for the Week of January 15

Number 5: Sarafraz K. Niazi, PhD, previews the new year and his hopes for the 

 for biosimilar approvals using examples from history of other scientific concepts that took time to gain traction.

 has announced that it will remove AbbVie’s blockbuster immunosuppressive drug Humira from some of its preferred formulary drug lists in favor of more affordable biosimilar options for the drug. Starting April 1, 2024, Hyrimoz and an unbranded version of Humira manufactured by Sandoz will be covered across all CVS formularies, with branded and unbranded near copies of Humira manufactured by Biocon covered on some reimbursement lists.

Number 3: IQVIA’s report on the impact 

 has had on Europe’s health care space identified ongoing challenges with biosimilar access and generating savings, calling for more policies focusing on fostering a sustainable market for years to come.

Number 2: As Regeneron gears up for a legal battle with 

 for its reference aflibercept, CareFirst files a lawsuit against Johnson & Johnson (J&J) for restricting biosimilar ustekinumab competition, and Celltrion and Accord BioPharma file with the FDA to approve their respective biosimilar candidates.

 (EMA) granted marketing authorization to Uzpurvo, the first biosimilar to reference Stelara (ustekinumab). The biosimilar is indicated for Crohn disease, psoriatic arthritis, and plaque psoriasis.

Here are the top 5 biosimilar articles for the week of January 15, 2024. 

The Top 5 Biosimilar Articles for the Week of January 8, 2024. 

 found that combination therapies featuring trastuzumab biosimilars and other common cancer medicines were safe and effective in patients with breast cancer.

Number 4: Sarafraz K. Niazi, PhD, previews the new year and his hopes for the end of 

clinical efficacy testing for biosimilar approvals

 using examples from history of other scientific concepts that took time to gain traction.

 from Europe demonstrated that switching from Humira (reference adalimumab) to SB5 biosimilar was effective and safe for adults with inflammatory diseases, further supporting that SB5 can serve as a lower-cost alternative to the originator.

Number 2: The regulatory structure of biosimilar development can be safely streamlined and made 

, wrote authors from Sandoz, Fresenius Kabi, Boehringer Ingelheim, and Samsung Bioepis in an opinion article published in BioDrugs.

 has announced that it will remove AbbVie’s blockbuster immunosuppressive drug Humira (adalimumab) from some of its preferred formulary drug lists in favor of more affordable biosimilar options for the drug. Starting April 1, 2024, Hyrimoz and an unbranded version of Humira manufactured by Sandoz will be covered across all CVS formularies, with branded and unbranded near copies of Humira manufactured by Biocon covered on some reimbursement lists.

Here are the top 5 biosimilar articles for the week of January 8, 2024. 

The Top 5 Center for Biosimilars Articles for the Week of January 8

Dr Prerakkumar Parikh talks about recent FDA approvals for ms biosimilars and the first tocilizumab biosimilar

Dr Prerakkumar Parikh Reacts to FDA Approvals for First Neurology, Tocilizumab Biosimilars

Prerakkumar Parikh, PharmD, director of specialty clinical solutions at Magellan Rx Management, gives insight into the growing world of biosimilars and the role formulary placement plays in biosimilar adoption.

In the second half of 2023, the FDA approved the first 

, which is also the first neurology and first biosimilar indicated for multiple sclerosis, as well as the first 

. Additionally, the FDA approved the first 

From a PBM's perspective, what was your reaction to the FDA approvals of the first MS biosimilar and the first tocilizumab biosimilar?

Yeah, [these are] exciting times as more biosimilars are flowing to the market, especially for newer categories like multiple sclerosis. I'm pretty sure we will see some market shifts happening in that category. Interesting, both [the natalizumab and tocilizumab products] are under the medical benefit right now. So, I think it will probably follow the same success stories of the oncology biosimilars.

Can you explain the role of formulary placement and tiering by PBMs and how these decisions affect the cost-sharing burden for patients who choose biosimilars over reference biologics?

Absolutely. The tiering for some of the biosimilars that have came out are on the specialty tier. So far on the on the pharmacy benefit side, we are seeing the adalimumab biosimilar on that specialty tier along with the brand name product, Humira. So, what that will do is it will allow for access. At the same time, if you have a low-WAC [wholesale acquisition cost] biosimilar at the same level as Humira and if a patient is paying a percentage co-insurance on that specialty tier, a low-WAC biosimilar is going to reduce that cost for the patient as well.

Prerakkumar Parikh, PharmD, director of specialty clinical solutions at Magellan Rx Management, reacts to recent FDA approvals for the first natalizumab and tocilizumab biosimilars.

The Top 5 CFB Articles for the Week of January 1

top 5 most-read rheumatology stories of 2023

 included the changing market dynamics in the adalimumab space, including new launches and interchangeability labels, as well as the addition of Stelara and Enbrel to the list of originators up for Medicare price negotiation.

 include the US market launch of Fylnetra, the sixth pegfilgrastim biosimilar on the market, the FDA approval for an autoinjector pegfilgrastim biosimilar, and more.

top 5 most-read ophthalmology stories of 2023

 concerned clinical results, approvals, and launches for ranibizumab and aflibercept biosimilars.

top 5 most-read regulatory stories of 2023

 covered the FDA approvals for the first ustekinumab biosimilar and the first subcutaneous infliximab product, as well as other regulatory updates.

regulatory structure of biosimilar development

 can be safely streamlined and made more efficient and less costly, wrote authors from Sandoz, Fresenius Kabi, Boehringer Ingelheim, and Samsung Bioepis in an opinion article published in BioDrugs.

Here are the top 5 biosimilar articles for the week of January 1, 2024. 

The Top 5 Biosimilar Articles for the Week of January 1

The Top 5 Biosimilar Articles of 2023

 on the market: Fresenius Kabi's Idacio (adalimumab-aacf) and Biocon Biologic's Hulio (adalimumab-fkjp). The launches come after 5 launched over the Fourth of July weekend.

Number 4: After years of waiting and legal battles, the first of the 

8 adalimumab biosimilars expected to launch in July 2023

 have entered the market: Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), Coherus Biosciences’ Yusimry (adalimumab-aqvh), Organon and Samsung Bioepis' Hadlima (adalimumab-bwwd), and Sandoz' Hyrimoz (adalimumab-adaz).

 (J&J) over the former’s ustekinumab biosimilar referencing Stelara, delaying the projected launch of the candidate from late 2023 to January 2025.

Number 2: In a real-world study in India, patients with ankylosing spondylitis (AS) who were treated with the 

 for 10 weeks showed improvements in disease activity that persisted through 48 weeks.

updated look on the adalimumab biosimilars

 that are coming down the US pipeline as well as what stakeholders need to know and how they can prepare ahead of the US launch of 8 adalimumab biosimilars in July 2023.

Here are the top 5 biosimilar articles for 2023.

Cencora's Brian Biehn and Corey Ford discuss biosimilar regulatory frameworks and improvements

Cencora's Brian Biehn and Corey Ford Recommend Adaptations for Biosimilar Regulatory Frameworks

Brian Biehn, senior director of biosimilar commercialization, and Corey Ford, vice president of reimbursement and policy insights at Cencora (formerly AmerisourceBergen) describe different avenues for regulatory agencies to improve biosimilar promotion and create a sustainable biosimilar industry.

Visitors can listen to the full version of this interview in the next episode of 

Not So Different: a podcast from The Center for Biosimilars

In what ways do regulatory frameworks need to adapt to accommodate the growth of biosimilars, and what impact might this have on the competitive landscape of the biopharmaceutical industry?

We support any kind of regulatory change that's going to promote biosimilars. Right now, there's a push from our manufacturer partners to find any way that they can reduce their development costs. These are not like pure generics; [biosimilars] are much more costly to make. We're talking hundreds of millions of dollars to develop these. So the thing that we hear from our manufacturer partners all the time is how can we reduce those costs [and] how can we become more efficient and develop more biosimilars, which I think everyone in the industry is pushing for. 

We promote anything that the legislators are looking to do or regulatory changes are looking to do to promote biosimilars and reduce those costs. I would say on the flip side of that, we do need to be careful of any changes where we potentially reduce the need for [for example,] starting clinical studies [as that can] impact the view of patients and providers in biosimilars. So, we still need to keep that confidence in these products—that they are the same as their brand counterparts. We need to look at that balance and make sure we still have that balance when we make these changes. But we are in favor of any changes that can be done to help our manufacturing partners reduce those development costs.

Now, I'll kind of tackle this from the CMS side, where we think about this from a Medicare perspective, specifically. By and large, I think from a Cencora standpoint, we're also very supportive of trying to enhance patient access within these government programs to biosimilars, and I think that also mirrors, frankly, how we have partnered with our manufacturer partners on this as well. 

One thing to continue thinking about as we get more and more—which we're in the process right now with trying to have the regulatory guidance for the party redesign—is still trying to maintain some of those very important beneficiary protections. As I mentioned, with higher liability for plans, CMS is trying to strike the proper balance between offering plans [with] that flexibility to manage the Part D benefit, while still also building in strong beneficiary protections. 

It's going to be very important knowing what plans are having to incur now that a lot of these beneficiary protections are still put in place, like the formulary review process that CMS says is still very rigorous to make sure that patients have a wide range of access to not just drugs and drug classes specifically, but also the types of products—both reference products and biosimilars.

Brian Biehn and Corey Ford from Cencora suggest improvements to current regulatory frameworks to better promote biosimilars for US patients and ensure market sustainability.