Hi, I’m Skylar Jeremias for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.

Here are the top 5 biosimilar articles for the week of January 23, 2023.

Number 5: IQVIA’s Global Use of Medicines Report for 2023 has revealed increased uptake of biosimilars around the world and predicted that biosimilars could generate 

, 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.

Number 3: Patent litigators from Fish & Richardson, an intellectual property law firm, regaled audiences during a webinar covering all the big biosimilar regulatory and legal decisions throughout 2022, including 

Number 2: Sophia Z. Humphreys, PharmD, MHA, BCBBS, of Sutter Health in Sacramento, California, detailed the regulatory decisions from 2022, what's to come in 2023, and how the US biosimilars market is 

 for their respective license partnerships; Samsung Bioepis sped up interchangeability study for its adalimumab biosimilar; Dong-A ST shared positive phase 3 results for its ustekinumab biosimilar.

To read all of these articles and more, visit 

Videos

The Top 5 Biosimilar Articles for the Week of January 23

Here are the top 5 biosimilar articles for the week of January 16, 2023.

 STADA Arzneimittel and Xbrane Biopharma’s Ximluci, a ranibizumab biosimilar referencing Lucentis, for the treatment of retinal conditions.

Number 4: The China National Medical Products Administration (NMPA) approved Bio-Thera Solutions’ 

 (BAT1806) referencing Actemra for the treatment of several rheumatic conditions.

Number 3: Alvotech announced that a phase 1 pharmacokinetic study for its 

 for Celltrion Healthcare’s bevacizumab biosimilar (Vegzelma) referencing Avastin for the treatment of multiple forms of cancer.

 of biosimilars found that while the United States had significantly higher prices, the uptake in Germany and Switzerland, 2 European countries with national mechanisms for drug price negotiation, was slower.

The Top 5 Biosimilar Articles for the Week of January 16

Here are the top 5 biosimilar articles for the week of January 9, 2023.

Number 5: IQVIA’s eighth edition of its Impact of Biosimilar Competition in Europe report 

 in many countries throughout the region. However, not every country has great adoption rates and companies may have a harder time choosing which molecules to invest in for biosimilar development.

Number 4: Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, demonstrated why regulatory bodies in the United States 

 economic evaluations when reviewing regulatory data for biosimilars in his latest column.

Number 3: Celltrion Healthcare submitted a biologics license application (BLA) to the FDA for its 

 allowing for subcutaneous administration (Remsima SC).

Number 2: The authors of a retrospective real-world study of patients with hidradenitis suppurativa treated with adalimumab concluded that switching patients between adalimumab products risked a greater likelihood of

Number 1: Alvotech, an Iceland-based company, announced that the 

 its biologics license application (BLA) for its proposed ustekinumab biosimilar referencing Stelara. The company said it expects the FDA’s decision in the second half of 2023.

The Top 5 Biosimilar Articles for the Week of January 9

Ian Henshaw, senior vice president and global head of biosimilars at Biogen, gives his thoughts on the necessity of clinical efficacy testing for biosimilar approvals, switching studies to establish interchangeability, and the promotion of biosimilars within company environmental and social impact reports.

Lately, there have been a number of efforts to try to remove clinical efficacy testing for biosimilars and to remove switching study requirements for establishing interchangeability. What is Biogen’s view on these efforts and do you think removing these requirements would create more confusion about biosimilar safety?

The intent of these discussions is to maybe open up the market. Some may see it as to lower the threshold. But we should recall that the body of evidence to get a regulatory approval is generally only the preclinical aspect. So, it's about the technical process, the manufacturing, etc. If we divide the clinical studies into 2, phase 1 and/or phase 3, you need to probably keep phase 1 for the right reasons, except in certain circumstances where you don't want to be putting an active drug into, say, an eyeball. 

If you did, under the scenario that you did eliminate a phase 3 study, because the body of the totality of evidence found—for example, in Europe, is 1 million patient-years of data—you would then say, "Does that prove anything? Is it necessary in terms of confirming comparability between the innovator and the biosimilar?" In that circumstance, you wouldn't do switching studies, and therefore, you wouldn't have an interchangeability discussion. 

But I think the discussion is, if the body of evidence is within the early preclinical stage, which is about comparability within certain tolerances and also includes a phase 1, you've probably covered most of the question marks around switching from one biologic to another biologic to another biologic, which, by the way, is what happens when you go from one innovative batch to another innovative batch to another innovative batch. They're all similar to the first reference batch, and I think that is where the body of evidence and real-world data starts to come to play and actually opens up the possibilities of this marketplace.

Earlier this year, The Center for Biosimilars

 wrote a piece on how companies are using their biosimilar development portfolios as part of their environmental and sustainability reports and social impact reports. Why is it important for companies to establish how their biosimilar portfolios impact the world?

So, commitment to ESG [environmental, social, and corporate governance] is a long-term journey for everybody. That's number 1. I think number 2 is, we have been reporting on that at Biogen for some time. And number 3, when we look to the future and what we can do, most importantly, what our customers are now asking us to provide evidence on, they're asking us to provide evidence of our ESG credentials within some of the contract structure of tenders and contracts. And I think that's good. That's a step forward. Again, that will move forward as we start to think about some of our COP [United Nations Climate Change Conference] commitments across the across the world.

Ian Henshaw, senior vice president and global head of biosimilars at Biogen, shares his thoughts on whether clinical efficacy and switching studies to establish biosimilar safety are necessary, a hotly debated topic in the biosimilars industry.

Biogen's Ian Henshaw Weighs in on Clinical Efficacy, Switching Studies for Biosimilars

Hi, I’m Hayden Klein for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.

Here are the top 5 biosimilar articles for the week of December 19, 2022.

 Biogen’s biologics license application for a biosimilar candidate (BIIB800) referencing Actemra (tocilizumab) for review. If approved, the drug will be used to treat several conditions, including rheumatoid arthritis, idiopathic polyarthritis, idiopathic arthritis, and sclerosis-associated interstitial lung disease.

Number 4: A phase 1 study in China found that pharmacokinetics, safety, and immunogenicity were similar between the 

 RD12014 and the reference product (Victoza) in healthy male participants.

Number 3: Despite recent steps taken by the FDA to streamline approvals and increase availability for biosimilars, biosimilar adoption has been slow and 

 in the United States, signaling that more needs to be done to encourage adoption, according to experts at a virtual workshop hosted by the FDA and the University of Maryland.

Number 2: Johnson & Johnson’s Janssen unit 

 against Amgen, claiming the latter infringed on the former’s patents when creating its ustekinumab biosimilar, and Express Scripts announced that it would add adalimumab biosimilars to formulary.

 of its adalimumab biosimilar Idacio (adalimumab-aacf), making it the eighth biosimilar referencing Humira (adalimumab) to be approved in the United States.

The Top 5 Biosimilar Articles for the Week of December 19

Ian Henshaw, senior vice president and global head of biosimilars at Biogen, recapped the launch of Biogen's and Samsung Bioepis's ranibizumab biosimilar as well as how leveraging campaigns like the International Generic and Biosimilar Medicines Association's Global Biosimilars Week can help boost biosimilar adoption rates.

Biogen and Samsung Bioepis had a big year with the launch of Byooviz, the first ophthalmology biosimilar and the first ranibizumab biosimilar to enter the US market. What has been your initial experience with this launch and how do you expect this market will play out in 2023?

So, from the voice of the customer, we've heard excitement about Byooviz approval and launch into the marketplace. The ophthalmology market in this area, [Medicare] Part B in the US, is probably characterized by a lot of private equity groups that run ophthalmology clinics. Plus, there's a group of new operators that are operating in retinal specialist centers with maybe 1 or 2 physicians. And so you get 2 different aspects of the business. 

From that perspective, it's been well received. In terms of insurance coverage, again, insurance coverage is being positive in terms of speed to getting that coverage applied. And then, I think in terms of the programs that we've got in place, like patient services, etc, it's been an overall positive response.

Why are companies like Biogen so focused on investing in biosimilar development, especially in newer markets, such as ophthalmology and rheumatology?

Firstly, when people look at biosimilars from a company perspective, they're looking at it from an opportunity for revenue or to facilitate efficiencies around production or to deploy their technical knowhow, particularly in biotech. So, what you get is a number of different synergies. But on top of that, if you think about how we are relieving costs out of [Medicare] Part D or Part B, and then you're also putting new products into these areas, it has a very sort of balanced response with payers and providers of care in these areas. So, that's number one. What you're providing is savings and an opportunity for those savings to be used, either in new innovations or improving patient access. 

What we've seen, specifically on patient access and with reference to our business in Europe, we see a range of up to doubling of access, but generally, the overall access is about 2 times over the period. And then another aspect that we believe we've seen in some cases and in some countries is an overall improvement in patient pathway care. 

So, if you look at it through those 2 points, you actually get a much more holistic response. [With our] investment in that, the balance in terms of the pipeline, our mission in neurology, and also our mission to try and transform more lives, we get a good response.

Recently, Global Biosimilars Week passed, for which The Center for Biosimilars was a media partner. What is the importance of having this annual campaign and how can it be leveraged to improve global perception and adoption of biosimilars?

So, I think the singular fact that I found most interesting about Global Biosimilars Week was that there are over 600 biosimilars approved around the world. And that was a global context. If you boil that down to what's happening in the US, or you boil it down to what's happening in Europe, you get various stages of that journey.

Of the 89 approvals in Europe, it's covered 92 molecules. Now, the news is there are more than 100 different biologics being used in the marketplace to date. So, there is scope for more expansion. That's good. It's good for patients. It's good for potential savings on overburdened health care systems, whether it's pandemic- or age-related or just new areas that they want to invest in or treat. And you get this sort of dynamic, which I think we've only just started to appreciate, of the potential or the ability for biosimilars to unlock the potential in health care, as well as provide bigger access to patients around the world.

Ian Henshaw, senior vice president and global head of biosimilars at Biogen, describes the importance of awareness campaigns like the International Generic and Biosimilar Medicines Association's Global Biosimilars Week and how these initiatives can be leveraged to improve biosimilar adoption and acceptance.

Biogen's Ian Henshaw: Why Global Biosimilars Week Is Important for Improving Adoption

Here are the top 5 biosimilar articles for the week of December 12, 2022.

, Sarfaraz K. Niazi, PhD, looked into the domestic and international support for removing interchangeability for biosimilars in the United States.

Number 4: The Accreditation Council for Medical Affairs (ACMA) is launching a 

 for health care professionals to become Board Certified Biologics and Biosimilars Specialists.

 Magellan Rx Management, a popular pharmacy benefit manager (PBM) in the specialty pharmacy space.

Number 2: The FDA has accepted Biogen’s biologics license application for a 

 candidate (BIIB800) referencing Actemra for review.

Number 1: Following their initial European launch of the drug, Alvotech and STADA Arzneimittel launched their adalimumab biosimilar referencing Humira in 

: Belgium, Bulgaria, Croatia, the Czech Republic, Latvia, Romania, and Slovenia.

The Top 5 Biosimilar Articles for the Week of December 12

Ryan Haumschild, PharmD, MS, MBA, director of pharmacy services at Emory Healthcare and Winship Cancer Institute, tackles how stakeholders can collaborate and utilize market data to effectively boost biosimilar uptake.

How can different stakeholders work together to ensure improved biosimilar utilization across disease states?

I think that’s one of the things that we want to continue to expand upon. How do we get good biosimilar use in oncology, but then good biosimilar use in the immunology disease states, such as rheumatology and gastroenterology? And believe it or not, there’s different uptakes between the different disease states. If we’re using biosimilars and we’re extrapolating data to treat patients in the curative intent, how can we not extrapolate data from gastroenterology to rheumatology, and then start to look at interchangeability?

There’s going to be a never-ending appetite for data, and that’s okay because we’re data driven. How can we leverage the experiences we’ve had and the similar outcomes between reference projects and biologics, and move that into the biosimilar space, so that we can make more timely approvals? Not just wait for every single study and every single patient. And also look at switching immunogenicity and feel comfortable moving forward biosimilars across the board.

Dr Ryan Haumschild Discusses Stakeholder Collaboration to Boost Biosimilar Adoption

Here are the top 5 biosimilar articles for the week of December 5, 2022.

Number 5: Now that the world population has reached 8 billion, Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, took a look at how high-income countries can 

 to lifesaving medicines to the 7 billion people who have limited access to biosimilars.

Number 4: The third in a series of clinical studies evaluating pharmacokinetics (PK) and pharmacodynamics (PD) of Biocon’s recombinant human insulins compared to their reference products, found 

 between the biosimilar insulin-70/30 and Humulin-70/30.

Number 3: In November, several global agencies 

, the European Union approved another ranibizumab biosimilar, and a US Senate bill to rid switching study requirements for interchangeability was introduced to Congress.

Number 2: The Accreditation Council for Medical Affairs (ACMA) is launching a 

Number 1: Capstone has announced that its 

 received positive opinions from the European Medicines Agency and Health Canada, signaling approvals may be on the horizon, and the acquisition of Viatris’ biosimilars portfolio by Biocon Biologics is officially complete.

The Top 5 Biosimilar Articles for the Week of December 5

John Gabrielson, senior vice president at JSR Life Sciences and head of Similis Bio, talked about the challenges associated with launching a business venture like Similis Bio and how Similis Bio's business model differs from other biosimilar developers and their spin-offs.

Similis Bio is a relatively new company in the biosimilars game, being a biopharmaceutical business division of JSR Life Sciences. However, they are not the only new players—Novartis has announced spinning off Sandoz into a separate company and Merck has done the same with Organon. How is Similis Bio different from other biopharmaceutical companies and what are some of the challenges associated with launching a new company in this space?

Yeah, Similis Bio actually differs quite a bit from the spin-offs you mentioned. One thing, Similis is focused exclusively on preclinical CMC [chemistry, manufacturing, and control] development of biosimilars. So, this includes things like analytical development, cell line and process development, and formulation development. From there, we find partners to take the products forward through clinical development and commercialization.

The other thing I wanted to mention, we aim to introduce new efficiencies into the biosimilar development paradigm, like multi-use data and purpose-built information packages. So, I think that also distinguishes us.

You also asked about challenges. Launching a new venture in the biosimilar space does have unique challenges. It's a rapidly growing sector of the industry and it's a highly competitive one. The market's crowded and we believe it's also, at this time at least, a very inefficient marketplace. And that's an area where I think we can really help.

We're reimagining what biosimilar development can look like in a global marketplace where the winning products will be both cost competitive, and have top tier quality.

Similis Bio’s business model functions by helping biopharmaceutical companies navigate the drug development process, improve efficiency, and reduce cost. How does Similis Bio work with other companies to achieve those goals and what does Similis Bio look for in a company partnership?

Yeah, I appreciate the question on the business model and the partnership. So, first of all, our business model really seeks to do 2 things. We want to make biosimilar development faster and make it more cost effective.

We accelerate development by creating made to order assets ready to license eliminating, in some cases, up to 2 years of preclinical development and allowing companies to start nonclinical and clinical development immediately. We make biosimilar development more cost effective by making noncompetitive reference product information available to companies on a nonexclusive basis.

As it relates to our business model, we develop biosimilar products that are highly similar to the reference products and ready to enter clinical trials. Compared to novel biologics, biosimilars achieve most of their value during preclinical development before even 1 human is dosed. So, in this way, we're positioning Similis as a value creation engine for biosimilars.

I think a good partnership leverages the strengths and resources of each party. So, we look for companies with a long-term mindset, who value quality and with the resources to take the preclinical clinical biosimilars that we develop through clinical development and, eventually, marketing authorization. We need to have aligned values with our partners, and notably, this would include a mission to make high-quality biologics globally accessible.