Hi, I’m Justina Petrullo 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 October 2nd, 2023.

Number 5: Compared with other biologics frequently used in China for moderate-to-severe psoriasis, 

 of its ustekinumab biosimilar referencing Stelara in Japan for autoimmune conditions. The company also released an update on the US filing for its adalimumab biosimilar.

Number 3: With the European Commission's (EC) 

, Europe received its first natalizumab biosimilar and first biosimilar to treat multiple sclerosis (MS), while Coherus Biosciences received a complete response letter (CRL) for its biosimilar for Neulasta Onpro.

Number 2: Patients with inflammatory bowel disease who underwent a switch from reference infliximab to a biosimilar and then back to the originator were 

 their treatment than patients who underwent a single switch from the originator to a biosimilar.

Number 1: Drug maker payments to ophthalmologists were associated with the choice of 

 for age-related macular degeneration (ARMD) that could increase Medicare costs, but biosimilars could help.

To read all of these articles and more, visit 

Videos

Here are the top 5 biosimilar articles for the week of October 2, 2023.

The Top 5 Biosimilar Articles for the Week of October 2

Here are the top 5 biosimilar articles for the week of September 25th, 2023.

Number 5: Although removing the requirement for clinical efficacy testing for biosimilar approval would reduce development costs of biosimilars, representatives from several biosimilar manufacturers argued in the 

second day of the FDA’s development workshop

 that clinical outcomes will not be affected.

Number 4: Drug maker payments to ophthalmologists were associated with the choice of higher-cost therapies for age-related macular degeneration (ARMD) that could increase Medicare costs, but 

Number 3: A study evaluating the real-world impact of treating patients with inflammatory bowel disease (IBD) with an adalimumab biosimilar found that providing patient questionnaires early can be useful for 

Number 2: The European Commission approved the 

, which will be used to treat patients with age-related macular degeneration and diabetic macular edema.

 of a 3-part series, Sarfaraz K. Niazi, PhD, gave his take on the FDA's recent workshop dedicated to streamlining biosimilar development and his opinion on what the industry can learn from the webinar presenters.

Here are the top 5 biosimilar articles for the week of September 25, 2023.

The Top 5 Biosimilar Articles for the Week of September 25

Here are the top 5 biosimilar articles for the week of September 18th, 2023.

 between antidrug antibodies and nonresponse to biologic disease-modifying antirheumatic drugs (bDMARDs) in patients with rheumatoid arthritis (RA).

Number 4: Although removing the requirement for clinical efficacy testing for biosimilar approval would reduce development costs of biosimilars, representatives from several biosimilar manufacturers argued in the 

Association for Accessible Medicines (AAM)

 highlighted the value of biosimilars and generics, revealing that lower-cost versions of originator products accumulated $408 billion for the US health care system in 2022.

Number 2: Growing use of innovator biologics, including those with biosimilar competition, has led to increased 

 featuring regulators from around the world provided the regulatory perspective on how each government determines whether a biosimilar is clinically equivalent to their reference product, highlighting the science behind their development guidelines.

Here are the top 5 biosimilar articles for the week of September 18, 2023.

The Top 5 Biosimilar Articles for the Week of September 18

Here are the top 5 biosimilar articles for the week of September 11th, 2023.

Number 5: Switching from reference to biosimilar adalimumab was found to be 

, researchers cautioned that female patients may be at higher risk of discontinuation compared with their male counterparts.

 of the first 10 drugs chosen for price negotiation under the Inflation Reduction Act, including 3 biologics with no biosimilar competition.

Number 3: Perhaps the most significant development in the pharmaceutical industry in decades, crops of biosimilars are being 

. What lies next, in terms of legislation and the impact on pharmacists, remains to be seen.

 and positive recommendations for 2 biosimilars in Europe brought hope for more affordable biologics around the world. However, another settlement for a US ustekinumab biosimilar showcased that some barriers remain.

, a new subsidiary that will work with manufacturers to commercialize and coproduce biosimilars, beginning with an adalimumab product.

Here are the top 5 biosimilar articles for the week of September 11, 2023.

The Top 5 Biosimilar Articles for the Week of September 11

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, believes that adalimumab biosimilars will greatly impact the US health care system. However, whether interchangeable designations will affect the adoption of these products remains to be seen.

With states having different laws regarding interchangeability, new bills being introduced to Congress to eliminate switching study requirements, and only 4 biosimilars overall having an interchangeability designation, what is your view on the value of interchangeability?

Interchangeability introduces an additional cost. When the manufacturers are researching the medication during clinical trials, they are required to go through an additional step. And it's not just a little step; it's an extremely large step involving patients and clinical trials and millions and millions of dollars in additional costs to prove [basically] biosimilarity again, sort of. So, it's really kind of an extra step that's extremely costly, that is really just, again, proving that your medication is indeed the same thing as the reference product.

So I think the opinion that this is an extra, maybe unnecessary step is shared by many and that's why we're seeing these bills being introduced, and I think the bills make sense. They're very tactical. You know, “Here's what language we could remove from the 351(k) FDA approval pathway to kind of back that out and maybe simplify this process.” And not only simplify the process for manufacturers, but simplify the process for physicians, for prescribers, for pharmacists, and for the entire health care system.

Interestingly, for the one interchangeable biosimilar that we have in the adalimumab space today [Cyltezo], it is a higher-cost product. So I do believe that these additional clinical trials are unfortunately going to lead to higher costs being passed through to the product launch. And that's not really what any of us want to see. I love seeing these huge discounts that we're seeing on these new products with the low WAC [wholesale acquisition cost] strategies. And that's what we want to continue to see more of, and if we continue to add costs to the process to get the drug approved, it'll be more difficult for us to bring down this cost long term.

Do you think the interchangeable label will have an impact on adalimumab adoption or do you predict that adoption rates will be more like those in the interchangeable insulin space?

It's interesting; that's one of those kind of “predict the future” questions since we're still in early stages of this launch. However, Cardinal Health publishes a really nice 

, and we did publish one in 2023. And it did kind of clearly highlight that many providers prefer an interchangeability designation, in order to have a comfort level prescribing an adalimumab [biosimilar]. So even though we know this is a regulatory step, that is absolutely not a clinical designation. It's not a safety or efficacy designation; it's a regulatory designation only. Providers are being convinced that this may be a differentiator, and we do have some data supporting that—at least in the rheumatology space.

So will that impact market share? I think that will be determined in a lot of ways by the selections of the payers and the PBMs [pharmacy benefit managers] and the cost savings that's potentially passed to the patient. However, it's definitely not something that's going to hurt them at this particular point in time. I don't think that it is a bad thing to have interchangeability designation until we figure out as a country what we want to do with that longer term.

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, explains the value of interchangeability in the adalimumab space and predicts whether interchangeable biosimilars will become leaders in adoption.

Fran Gregory Weighs In on the Value of Interchangeability in the Adalimumab Market

Here are the top 5 biosimilar articles for the week of September 4th, 2023.

 for the first 6 months of 2023 reached $22.7 million, a nearly 600% year-over-year increase.

 industry’s future, with the approval of the first neurology biosimilar, growth projections from company quarterly expense reports, and several analyses about the health of the market.

reacted to CMS' list of the first 10 drugs

 chosen for price negotiation under the Inflation Reduction Act (IRA), including 3 biologics with no biosimilar competition.

Number 2: Single switching between approved biologics and biosimilars of tumor necrosis factor inhibitors (TNFis) were found to be 

Number 1: Stelara (ustekinumab) and Enbrel (etanercept), 2 originator medications that will face biosimilar competition within the next decade, were among the 10 preliminary drugs 

 under the Inflation Reduction Act (IRA).

Here are the top 5 biosimilar articles for the week of September 4, 2023.

The Top 5 Biosimilar Articles for the Week of September 4

Here are the top 5 biosimilar articles for the week of August 28th, 2023.

Number 5: Stelara (ustekinumab) and Enbrel (etanercept), 2 originator medications that 

 within the next decade, were among the 10 preliminary drugs chosen for Medicare price negotiation under the Inflation Reduction Act (IRA).

Number 4: A meta-analysis and systematic review of data on over 10,000 patients with rheumatoid arthritis (RA) found that etanercept, adalimumab, and infliximab 

Number 3: Dan Danielson, RPh, MS, senior director, market access solutions, at PrecisionValue, a market access marketing firm, explained 

 at play slowing down biosimilar uptake in the United States.

Number 2: Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, published her opinions on the 

future of biosimilars in the United States

, foreshadowing immense growth and a transformation of the US health care industry thanks to biosimilars.

 indicated for multiple sclerosis (MS), Sandoz’ Tyruko (natalizumab-sztn), a biosimilar referencing Tysabi (natalizumab).

Here are the top 5 biosimilar articles for the week of August 28, 2023.

The Top 5 Biosimilar Articles for the Week of August 28

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, explains the importance behind the FDA approval of Tyruko (natalizumab-sztn), the first neurology biosimilar and the first multiple sclerosis (MS) biosimilar to receive regulatory approval in the United States.

Tyruko was developed by Polpharma Biologics and will be marketed globally by Sandoz. The approval marks the fourth FDA approval for a biosimilar in 2023, following 

 (adalimumab-aaty), the autoinjector version of 

 (pegfilgrastim-cbqv), and the high-concentration version of 

What was your reaction to the FDA approval of the first neurology biosimilar, Tyruko, and why is this approval so important?

This is a really exciting approval. We have not had an approval in the neurology space [before]. This is a natalizumab biosimilar for relapsing forms of multiple sclerosis. It is extremely exciting because MS is such a debilitating disease. It's a very, very difficult disease to treat. These patients have many unmet needs, still, even with the number of treatments on the market today. There's still no perfect treatment for these patients.

So again, adding choices so that those patients can have more opportunity to potentially have a better experience with the biosimilar [or] maybe they see direct cost savings from the biosimilar. But I do think that choice [and] competition open the market to more treatment options for physicians and more options for patients as well.

This biosimilar is extremely big news. I know there's so much focus on the adalimumab biosimilars right now but introducing a brand new therapeutic area, with neurology and a biosimilar, is very, very exciting. And I'm really excited that the manufacturer [will be] able to bring this product to market and get FDA approval for this product. I'm really looking forward to it coming to market and providing more options for patients.

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, shares her reaction to the FDA approval of Tyruko (natalizumab-sztn), the first biosimilar approved to treat multiple sclerosis (MS).

Cardinal Health's Dr Fran Gregory Reacts to First MS Biosimilar Approval

Here are the top 5 biosimilar articles for the week of August 21st, 2023.

Number 5: Robert Zutaut, RPh, a clinical specialist from McKesson Provider Solutions, quantified the 

major barriers to adoption for biosimilars

 used to treat rheumatoid arthritis (RA) and some major considerations for health systems looking to address them.

Number 4: Ranibizumab biosimilar was found to be the most 

 for neovascular age-related macular degeneration (nAMD), according to a recent Japanese study.

Number 3: Sarfaraz K. Niazi, PhD, recapped his answers to a recent interview where he 

 on the future of the biosimilar industry in the United States.

Number 2: In STADA Arzneimittel’s first half of 2023 

, the company disclosed double-digit growth, suggesting that it could see profits hit an all-time high by the end of the year.

, the company revealed that sales for its biosimilars portfolio rose 106% compared with the same time frame the year prior.

Here are the top 5 biosimilar articles for the week of August 21, 2023.

The Top 5 Biosimilar Articles for the Week of August 21

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 August 14, 2023.

 with sintilimab and a bevacizumab biosimilar was cost-effective enough in patients with hepatocellular carcinoma (HCC) to warrant use of the biosimilar over the reference product (Avastin) without compromising safety or efficacy.

Number 4: A study on the stability of the adalimumab biosimilar candidate TUR01, a tumor necrosis factor-α inhibitor, found 

 of the drug substance and drug product were maintained under different temperatures.

Number 3: The Spanish Psoriasis Working Group 

 on the use of biosimilar medicines in patients with moderate to severe psoriasis, including its views on biosimilars as first-line treatment and nonmedical switching.

Number 2: Ranibizumab biosimilar was found to be the 

Number 1: Robert Zutaut, RPh, a clinical specialist from McKesson Provider Solutions, quantified the major 

 for biosimilars used to treat rheumatoid arthritis (RA) and some considerations for health systems looking to address them.