Justina Petrullo

The United States is going to have to wait and see whether adalimumab biosimilars will have sufficient uptake, and hopefully, they won't experience the adoption challenges observed in the diabetes space, according to Christine Baeder, the new chair of the Association for Accessible Medicines (AAM) and chief operating officer for US generics and biosimilars at Teva Pharmaceuticals USA.  

With the reauthorizations of the Biosimilar User Fee Act (BsUFA) and Generic Drug User Fee Act (GDUFA), the Inflation Reduction Act, and the US market introduction of adalimumab biosimilars, how do you see the generic and biosimilar industries developing over the next few years?

There's a lot of exciting possibilities. That's the good news. The bad news is if we don't take some action, and work together between regulators, legislators, and manufacturers, I don't know that patients are going to feel the benefit of that. So, GDUFA specifically, we made a lot of movement towards lifetime communication, and faster approval cycle. We could go farther, but we're happy that we made the progress we made.

The ideal state would be that the FDA very much partners in live time with manufacturers to get those drugs approved, especially first-to-market and complex generics. There tends to be sort of fits and starts; you submit a package of data, the FDA takes a few months to review it, you then get a letter back, you take a few months to review it, that goes back. Imagine a system where we can line everything up, and things move faster, and then we get to approvals faster. That’s, I think, everyone's ideal state, we're working towards getting there.

So, we made some progress on GDUFA, that's exciting. Adalimumab? We'll see what happens, right? I read the news, just like you do, and there's a lot of concern that we won't have the biosimilar uptake as quickly as we would like to have it. I also see that as an opportunity. So, if that does happen, what are we going to do from a policy and regulatory perspective to make sure we do better going forward? And how do we correct it? And how do we talk about incentives in a different way? So, it's all so exciting and full of possibility, it's just not clear to me what the answer is yet.

Eli Lilly just announced that it will significantly reduce the prices of their insulin products—including its recently launched insulin glargine biosimilar—and capping patient out-of-pocket costs to $35, in line with the Medicare Part D provision set out in the Inflation Reduction Act. What was your reaction to this news and do you think this could have an impact on insulin prices as a whole and the utilization of insulin biosimilars?

Insulin has been a challenging market for patients to feel any reduction in cost for a long time. So, I think everyone welcomes a different approach, and I certainly applaud Lilly for the for the actions that they've taken. I think it does beg a question; if you look at the insulin market and you look at Semglee [insulin glargine biosimilar] on how the incentives are structured and what's going on that you're not seeing the uptake of the biosimilars the way we would want to.

I'm very much watching Amgen, which just launched the first biosimilar to Humira [

], and if you notice, they also had a high-whack and a low-whack strategy, much like we saw with 

 in the insulin space. So, if that continues to happen, you have to wonder why that's happening; why the lower-priced item isn't moving and we're not getting the uptake. I think that is raising a lot of questions and driving a lot of conversation, and we're talking about it in a way that we haven't talked about it. So, it's exciting to me that maybe that's the start of some new set of incentives or a new structure that helps us get those savings all the way through to the patient.

Videos

Upon coming into her position as the new chair of the Association for Accessible Medicines (AAM), Christine Baeder discussed what she believes the future holds for biosimilars, good and bad, and the questions that still surround the insulin price cap.

Christine Baeder Discusses the Future of the Biosimilar Industry, Insulins

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 April 3rd, 2023.

 for the Biosimilar User Fee Act (BsUFA) meetings and how they influence the efficiency of the biosimilar approval process in the latest installment of his bimonthly column.

 to implement a biosimilar switching policy, following in the footsteps of Ontario and 7 other jurisdictions.

Number 3: Yukon, 1 of 3 Canadian territories, announced that it will implement a 

, following Newfoundland and Labrador’s announcement to move forward with a similar policy earlier this week.

 its insulin glargine biosimilar, Rezvoglar (insulin glargine-aglr), on the US market, making it the second interchangeable insulin biosimilar to become commercially available to American patients with diabetes.

Number 1: The Increasing Access to Biosimilars Act of 2023 (HR 1352), a bill that would direct HHS to 

establish a demonstration project within Medicare

 that would establish a shared savings model for biosimilars, was introduced to the House of Representatives.

To read all of these articles and more, visit 

Here are the top 5 biosimilar articles for the week of April 3, 2023.

The Top 5 Biosimilar Articles for the Week of April 3

Christine Baeder, the new chair of the AAM and chief operating officer for US generics and biosimilars at Teva Pharmaceuticals USA, talks about what’s first on the list in her new role, as well as the challenges that she expects to encounter and her plan of action.

What are the main goals and initiatives that you want to prioritize in your new role as AAM chair?

Certainly, my most important role is raising awareness of the generic industry, and the fact that, I think, we're approaching a crisis of sustainability. We're already starting to see some manufacturers leave the market for financial reasons, as well as less investment in new products. I think it's time that we all come together and speak with one voice and make sure that we remember that generics are a US success story. The legislators, the regulators, and the third-party industry works together and created this amazing thing, which is generic pharmaceuticals, which is something now that we all count on as the backbone of our health care system. Over 90% of prescriptions, less than 20% of the cost, by every definition, that's a success story, and it touches every family in the country. I don't think there's anybody who hasn't taken a generic drug at some point in time. So, it's important that we continue to foster and support that industry going forward.

What challenges in the biosimilar and generic spaces are you looking to tackle first and how do you plan to address them?

The first one is to try to talk about anything that doesn't support the additional sustainability of generics and the biosimilar space. We'll talk about them separately; they have somewhat different issues. The generic industry has been working for a very long time, and over time, what's happened is there has been the erosion of the incentives that make the system work really well. When I started in generics, when a generic product was launched, you would get to 80% utilization of generics within a very short period of time, let's call it 6 months. What we've seen is that innovative companies have been very successful as of late in having strategies that maintain their market share for a longer period of time, and those are things that just don't make sense to me. So that's one of the things that we would be tackling. We would support a legislative solution that says, if it's a generic medication, it’s offered on a generic tier for patients.

I think one of the challenges in discussing the generic industry is that people's perception is that the price of medication is too high. Generic medications are not expensive. The average copay for a generic medication is $6. So, there's something going on in the system that doesn't allow people to feel the benefit and the value that generic products bring. So, I would be fully supportive of a review of the value chain. I support pharmacists getting compensated for the work that they do; speaking to a patient, that can take a lot of time, people have a lot of questions and pharmacists are very trusted. And they're accessible. You can go into your pharmacy and talk to someone; you can’t always just drop by your doctor's office. So, I fully support that. And I recognize the value that the wholesalers bring in moving product from place to place, especially cold chain products, that's not easy to ensure that it's delivered within the temperature conditions that's required to make the medication work as it's supposed to. 

So, I'm not against other people in the value chain getting recognized for the value that they bring. But we do need to ensure that the savings that we create by bringing multiple generics to the market also impact the patient at the pharmacy counter, and that people are feeling the erosion of the price that's associated with market competition. Sometimes that doesn't happen, and why is a super complicated question. For sure, that's something that I would support looking into and trying to figure out how we can do better.

Biosimilars are a bit different, right? We don't have the built-in incentives that we have on the generic space. If you go back 20 or 30 years, I know I got trained on what's a generic when I went to the pharmacy counter, and they're like, “well, you can get this drug for $5. Or you can get the same drug in a different box and it's $40,” which creates just an inherent incentive at the patient level. And then that patient helps create that incentive at the health care practitioner level. They're like, “hey, I want the cheaper one, can I get the cheaper one?” We don't have that yet for biosimilars.

Biosimilars are actually approved as brands. So, all of the mechanisms at the state level and different legislation over the years that creates that national incentive for generics to be a more affordable option, don't exist in the same way yet for biosimilars. I would certainly encourage that we continue to look at, what do we need to do to create an incentive down to the patient level for biosimilar utilization? In addition, if you go up one more step to health care practitioners, there's really not an incentive there either because the patient isn't saying, “hey, that's cheaper,” the patient’s saying “well, I can get this the same one I've always got at the same price. So why wouldn't I just do that?” And the doctor has to do nothing to do what he or she has always done, as opposed to learn the names of 10 other new drugs and remember which one is which one he wants to give, which is a heavier lift than just doing nothing. So, we need to create incentives at every piece of the value chain to help biosimilars be successful.

Upon coming into her position as the new chair of the Association for Accessible Medicines (AAM) as well as chief operating officer for US generics and biosimilars at Teva Pharmaceuticals USA, Christine Baeder discusses her primary goals in this position, and the challenges that accompany them.

Christine Baeder Discusses Generic Awareness and Challenges that Lie in Biosimilar in Generic Spaces

 of this year, Alvotech announced that a marketing authorization application filing for AVT04 was accepted by the European Medicine Agency and had a biologics license application accepted for review by the US FDA in 

 between AVT04 and reference product (RP) ustekinumab in a pharmacokinetic (PK) study in healthy volunteers.

 in the European Union and licensed in the United States.

Investigators conducted a double-blind, 3-arm, parallel-group study of 298 randomized participants in a 1:1:1 ratio; 98 received AVT04, 99 received EU-RP and 97 received US-RP as a single 45 mg subcutaneous injection on day 1.

The primary endpoint was the comparison of PK parameters of maximum serum concentration (Cmax) and area under the concentration-time curve from time zero to infinity (AUCinf) between AVT04 and both RPs, and between EU-RP and US-RP. Further endpoints included additional PK parameters, safety, tolerability, and immunogenicity.

Results showed that mean serum concentration-time profiles were similar for AVT04, EU-RP, and US-RP Mean values of the primary PK endpoints AUCinf and Cmax were similar.

After protein content normalization, the 90% CI of the geometric mean ratios were contained within the prespecified margins of 80% and 125% in all 6 pairwise comparisons:

Cmax: 95% CI, 95.5-110.7 for AVT04/EU-RP; 95% CI 91.5-106.2 for AVT04/US-RP; and 95% CI, 96.8-112.4 for US-RP/EU-RP

AUC0-inf: 95% CI, 101.5-18.8 for AVT04/EU-RP; 95% CI, 95.9-112.6 for AVT04/US-RP; and 95% CI, 97.6-114.4 for US-RP/EU-RP

Further results supported bioequivalence, with the additional mean systemic PK parameters in the AVT0 group found to be comparable with the EU-RP and US-RP treatment groups. The frequency of anti-drug antibodies, neutralizing antibodies, and local administration site reactions between treatment groups were similar.

“AVT04 was safe and well-tolerated, with a safety and immunogenicity profile similar to EU-RP and US-RP,” they concluded.

The investigators found that the analysis of bioequivalence supported the evaluation of PK similarity between AVT04 and EU-RP and US-RP.

 between candidate biosimilar AVT04 and reference ustekinumab (Stelara).

 Ustekinumab is a safe and effective treatment for psoriasis, and biosimilars to the originator may increase treatment accessibility. Investigators evaluated therapeutic equivalence of AVT04 and RP in a confirmatory efficacy and safety study in patients with moderate-to-severe chronic plaque psoriasis. 

Investigators randomized 581 subjects in a double-blind, 2-arm, parallel group, active control study at a 1:2 ratio to receive AVT04 (n = 194) or RP (n = 387), 45 mg (≤100kg) or 2 x 45 mg (>100 kg) subcutaneously on day 1, followed by the same dose 4 weeks later. The primary endpoint consisted of percentage improvement in Psoriasis Area and Severity Index (PASI) to week 12, static Physician’s Global Assessment (sPGA), Dermatology Life Quality Index (DLQI) safety, tolerability, and immunogenicity. The study continues to week 52.

At week 12, the 2-sided 95% Cis between treatment groups were within predefined equivalence margins of 10% (95% CI, ­–2.63 to 3.50), supporting the therapeutic equivalence assessment. DLQI score (12.5- vs 11.4-point improvement in the AVT04 vs RP groups, respectively) and sPGA (78.4% vs 80.5% achieving “clear” or “mostly clear” in AVT04 vs RP-treated groups, respectively) supported this assessment. The safety, tolerability, and immunogenicity profiles of AVT04 and RP were also similar.

“Analysis of percent change in PASI scores to Week 12 supports the assessment of therapeutic equivalence between AVT04 and RP. AVT04 was safe and well-tolerated, with a safety and immunogenicity profile similar to that observed for RP,” researchers concluded.

1. Alvotech to present clinical study data for AVT04, a proposed biosimilar to Stelara®, at 2023 American Academy of Dermatology (AAD) annual meeting. News Release. GlobeNewswire; March 17, 2023. Accessed March 20, 2023. 

https://www.globenewswire.com/news-release/2023/03/17/2629525/0/en/Alvotech-to-Present-Clinical-Study-Data-for-AVT04-a-Proposed-Biosimilar-to-Stelara-at-2023-American-Academy-of-Dermatology-AAD-Annual-Meeting.html

2. Berti F, Wynne C, Stroissnig H, et al; Assessment of bioequivalence between candidate biosimilar AVT04 and reference ustekinumab. Presented at: AAD 2023; March 17-21, 2023.

3. Stroissnig H, Feldman S, Berti F, et al; Assessment of therapeutic equivalence between candidate biosimilar AVT04 and reference ustekinumab. Presented at: AAD 2023; March 17-21, 2023. 

Articles

Posters presented by Alvotech at 2023 American Academy of Dermatology (AAD) annual meeting showcased proven bioequivalence and therapeutic equivalence candidate biosimilar AVT04 and reference ustekinumab (Stelara).

Favorable Equivalency Studies of Candidate Biosimilar AVT04 and Reference Ustekinumab

Here are the top 5 biosimilar articles for the week of March 20th, 2023.

Number 5: At the American Academy of Dermatology annual meeting, Samsung Bioepis shared 

 comparing its ustekinumab biosimilars (SB17) with the reference product (Stealara).

Number 4: In an article published in Frontiers in Pharmacology, 

 to improve the biosimilar regulatory system and refine biosimilar guidelines in China.

Number 3: Sarfaraz K. Niazi, PhD, explained why 

Indian manufacturers aren’t bringing biosimilars to the United States

 and how FDA policies and procedures discourage global companies from pursuing US market entry.

Number 2: The FDA's new artificial intelligence (AI)-based modeling on characterizing protein aggregation 

 the safety assurance of biosimilars and other therapeutic proteins.

interchangeability will not be a primary factor

 in driving the adoption of adalimumab biosimilars referencing Humira, contradicting predictions from other sources that believed the designation would impact prescribing habits

Here are the top 5 biosimilar articles for the week of March 20, 2023.

The Top 5 Biosimilar Articles for the Week of March 20

Here are the top 5 biosimilar articles for the week of March 13th, 2023.

Number 5: In part 2 of this 2-part series, Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, 

 guidelines from the World Health Organization (WHO) and how they view interchangeability and animal study requirements.

 a single-dose, prefilled autojector version of its pegfilgrastim biosimilar (Udenyca; pegfilgrastim-cbqv), for the treatment and prevention of febrile neutropenia, a common complication related to chemotherapy treatment.

 in the United States reasoned that increased market competition will help improve utilization rates, generate substantial savings, and encourage payers to cover biosimilars.

Number 1: The FDA and the European Medicines Agency (EMA) 

 for a trastuzumab biosimilar and an ustekinumab biosimilar, respectively, and Altos Biologics completed patient enrollment for a phase 3 trial assessing an aflibercept biosimilar.

Here are the top 5 biosimilar articles for the week of March 13, 2023.

The Top 5 Biosimilar Articles for the Week of March 13

Proposed biosimilar FYB201 is considered biosimilar to reference ranibizumab (Lucentis) in terms of clinical efficacy and safety in the treatment of patients with newly diagnosed subfoveal neovascular age-related macular degeneration (nAMD), and may be a new patient treatment option, according to a study 

This trial, called the COLUMBUS-AMD trial, was conducted to study the clinical equivalence of FYB201 and reference ranibizumab in patients with nAMD. It was an evaluation-masked, parallel-group, multicenter, 48-week, randomized phase 3 study to assess the clinical equivalence of FYB201 (Formycon/bioeq) with reference ranibizumab (Roche/Genentech) in clinical pharmacology, efficacy, and safety for the treatment of patients with treatment-naïve, subfoveal choroidal neovascularization caused by nAMD.

So, the primary endpoint consisted of change from baseline in best-corrected visual acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at 8 weeks prior to the third monthly intravitreal (IVT) injection. Biosimilarity of FYB201 to its originator was measured via a 2-sided equivalence test, with an equivalence margin in BCVA of 3 ETDRS letters.

It is known that AMD causes 8.7% of global blindness and is the most common cause of blindness in older people from high-income countries. nAMD is sometimes considered advanced AMD, and makes up 10% to 15% of all AMD cases, with more than 90% of AMD-related severe visual loss attributed to nAMD.

“Anti-[vascular endothelial growth factor] treatment for nAMD management carries a substantial burden for patients and healthcare systems, especially the cost of the medication. Treatment burden due to frequent and expensive injections may limit outcomes in clinical practice and affects and causes additional burden on insurance companies and their reimbursement policies.”

Reference product ranibizumab is an effective nAMD treatment that has a short half-life that minimizes systemic effects. To date, biosimilar use in ophthalmology has been limited. Currently, there are 2 approved ranibizumab 

 in the United States and 3 in the European Union, including FYB201, which is marketed as Cimerli in the United States and Ranivisio in Europe. FYB201 is also approved in the United Kingdom as 

. Cimerli is also the only ophthalmology biosimilar to have an 

. The use of ophthalmology biosimilars is still a 

In the study, a total of 477 patients were randomly assigned to receive either FYB201 (n = 238) or reference ranibizumab (n = 239), both in 0.5 mg by IVT injection in the study eye every 4 weeks. During the study, 199 patients in the FYB201 group and 189 patients in the reference ranibizumab group received the full 12 injections, and the number of missed injections was well balanced across treatment groups.

The patients came from sites in Austria, Czech Republic, France, Germany, Hungary, Israel, Italy, Poland, Russia, Spain, Ukraine, and the United Kingdom. This study presents findings relevant to the US population.

Ultimately, both groups saw BCVA improvement, with a mean improvement of +5.1 ETDRS letters in the biosimilar group and +5.6 letters in the reference product group at week 8. The analysis of covariance least squares mean difference for the change from baseline between FYB201 and reference ranibizumab was –0.4 ETDRS letters with a 90% CI of –1.6 to 0.9. Since the 90% CI was within the predefined equivalence margin, the primary end point was met.

In the US-relevant population, the mean BCVA improved in both groups, with a mean change of +5.1 letters in the biosimilar group and +5.6 letters in the reference ranibizumab group at week 8. The 95% CI for the difference was contained within the prespecified equivalence margin, and the primary end point was met. The same trends and effect similarity was seen between FYB201 and reference ranibizumab in the EU-relevant patient population.

Generally, the frequency and type of ocular adverse events (AEs) were comparable between the treatment groups, with most AEs of mild or moderate intensity, with no identifiable clinically relevant differences. Both drugs were well tolerated with no obvious safety concerns, with the safety profile of FYB201 consistent with the safety of the reference product. A total of 21.4% of FYB201 patients and 27.6% of reference ranibizumab patients experienced AEs linked to the IVT injection procedure.

The authors concluded by saying, “FYB201 can be considered biosimilar to reference ranibizumab in terms of clinical efficacy and local and systemic safety in the treatment of patients with newly diagnosed subfoveal nAMD. Biosimilar ranibizumab may offer a new treatment option for patients.”

Holz FG, Oleksy P, Ricci F, Kaiser PK, Kiefer J, Schmitz-Valckenberg S. Efficacy and safety of biosimilar FYB201 compared with ranibizumab in neovascular age-related macular degeneration. 

. 2022;129(1):54-63. doi:10.1016/j.ophtha.2021.04.031

Comparable safety and efficacy were found between biosimilar FYB201 compared with reference ranibizumab (Lucentis) for neovascular age-related macular degeneration (nAMD).

Phase 3 Study Demonstrates Comparable Safety, Efficacy Between Ranibizumab Biosimilar, Lucentis for nAMD

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

findings support a proposed natalizumab biosimilar

 (PB006) as the first biosimilar alternative to reference natalizumab (Tysabri) for treatment of relapsing-remitting multiple sclerosis (MS).

 for the full year of 2022 showed $1.95 billion of cash proceeds, which was largely driven by the sale of its biosimilar portfolio to Biocon Biologics.

Number 2: Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, 

 from the World Health Organization (WHO) have changed over time and whether those changes are beneficial for biosimilars in part 1 of this 2-part series.

 for its insulin products and cap out-of-pocket costs for insulin, the company shared that it will launch its interchangeable insulin biosimilar, Rezvoglar, at a 78% discount to the originator (Lantus).

The Top 5 Biosimilar Articles for the Week of March 6

Biosimilar natalizumab (biosim-NTZ) PB006 matched reference natalizumab (ref-NTZ, Tysabri) in efficacy, safety, and immunogenicity for patients with relapsing-remitting multiple sclerosis (RRMS), supporting proposed biosim-NTZ as a biosimilar alternative to ref-NTZ for treating RRMS.

This was the first phase 3 trial to compare biosim-NTZ to ref-NTZ. Currently, there are no natalizumab biosimilars 

The proposed biosim-NTZ PB006 is the first biosimilar monoclonal antibody developed for MS treatment, and no clinically relevant difference were found in this trial between the proposed biosimilar and the reference drug, according to the study published in 

The parallel-group, randomized, active-controlled Antelope trial took place between October 2019 and March 2021 in 48 centers across Belarus, Croatia, Georgia, Moldova, Poland, Serbia, and Ukraine. The last patient follow-up visit was on August 23, 2021.

Patients in these countries aged 18 to 60 years who had 1 or more documented relapses within the previous year and either 1 or more gadolinium-enhancing T1-weighted or 9 or more T2-weighted brain lesions, Kurtzke Expanded Disability Status Scale score of 0 to 5 (inclusive), and John Cunningham virus (JCV) index of 1.5 or less at screening were eligible. A total of 264 participants received treatment with biosim-NTZ (n = 131) or ref-NTZ (n = 133).

The primary end point was cumulative number of new, active lesions on MRI (new gadolinium-enhancing T1-weighted lesions and new/enlarging T2-weighted lesions without double counting) of the brain over 24 weeks. Other end points included further MRI parameters, annualized relapse rate, and Kurtzke Expanded Disability Status Scale score. The assessments for safety, tolerability, and immunogenicity included adverse events (AEs), laboratory evaluations, and testing positive for anti-JCV) antibodies and antinatalizumab antibodies. 

Administration of the drugs for participants consisted of intravenous infusions every 4 weeks of 300-mg biosim-NTZ or 300-mg or ref-NTZ (1:1 randomization), from week 0 to week 44, with an end-of-study visit at week 48. The ref-NTZ group was rerandomized at week 24, and 30 patients were switched to biosim-NTZ for the rest of the study.

After the administration of either the biosimilar or its reference, the model-based mean difference in cumulative number of new active lesions between the biosim-NTZ and ref-NTZ treatment groups at week 24 was 0.17 (least square means [SE]: biosim-NTZ, 0.34 [0.34]; ref-NTZ, 0.45 [0.28]; 95% CI, –0.61 to 0.94 within the prespecified margins of ±2.1).

Additionally, no significant observed differences between treatment groups across the secondary efficacy end points, safety, tolerability, or immunogenicity assessments were found.

“Notably, the overall AE profile for patients who switched from ref-NTZ to biosim-NTZ was similar to patients continuing ref-NTZ treatment and did not indicate any new or increased risks associated with switching to biosim-NTZ.”

The most reported treatment-emergent adverse events among all treatment groups were nervous system disorders and infections and infestations. Importantly, the study investigators found that 1 or more of the 3 stratification factors (absence/presence of gadolinium-enhancing lesions, presence of T2 lesions, JCV status) were incorrectly recorded at randomization for 62 of 265 patients after database lock. The imbalanced strata risk was found to be low, and the integrity of the data was not affected.

An aspect of the study that might be considered a limitation is the small sample size in the ref-NTZ/biosim-NTZ switch subgroup.

The researchers concluded that, “The results from this phase 3 trial support biosimilarity of proposed biosimilar natalizumab PB006 to its reference medicine in RRMS.”

Hemmer B, Wiendl H, Roth K, et al. Efficacy and safety of proposed biosimilar natalizumab (PB006) in patients with relapsing-remitting multiple sclerosis: the antelope phase 3 randomized clinical trial. 

. Published online January 23, 2023. doi:10.1001/jamaneurol.2022.5007

Phase 3 study findings support a proposed natalizumab biosimilar (PB006) as the first biosimilar alternative to reference natalizumab (Tysabri) for treatment of relapsing-remitting multiple sclerosis (MS).


Comparable Safety, Efficacy Between First Proposed Natalizumab Biosimilar, Reference for MS

Here are the top 5 biosimilar articles for the week of February 27th, 2023.

Number 5: In Cardinal Health’s 2023 Biosimilars Report, more than 60% of surveyed providers said 

they would only want to prescribe adalimumab biosimilars

 with interchangeability designations, suggesting the label may have a greater impact on uptake than originally expected.

Number 4: In theory, by offering a lower-cost treatment option, biosimilars would help drive access for countless patients who simply could not afford the brand-name biologic. However, biosimilars have also 

 of the US health care system and its market forces.

Number 3: Panelists at the annual meeting of the International Generic and Biosimilar Medicines Association (IGBA) 

 into the current state of the global biosimilar and generic markets and why government agencies need to leverage these medicines to address challenges in the pharmaceutical space.

 with Formycon for an ustekinumab biosimilar; Similis Bio partners with Novel351K to co-develop 3 biosimilars; and Celltrion Healthcare launched its bevacizumab biosimilar in Japan.

Number 1: Jacqueline Corrigan-Curay, MD, JD, principal deputy center director of the FDA's Center for Drug Evaluation and Research, 

 at Access 2023 on how the Biosimilar User Fee Act and the Generic Drug User Fee Act have developed over the last year.

Here are the top 5 biosimilar articles for the week of February 27, 2023.