Justina Petrullo

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 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.

To read all of these articles and more, visit 

Videos

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

Researchers saw substantial improvements in 

 in patients with osteoporosis after treatment with biosimilar teriparatide for a year or more, according to 

The biosimilar teriparatide can be weighed as an effective treatment option in female and male patients with osteoporosis. Teriparatide is a recombinant analog of the parathyroid hormone and an anabolic treatment approach for osteoporosis.

Researchers were trying to review the effectiveness of biosimilar teriparatide in patients with osteoporosis after at least a year of treatment.

First, a multi-center, single-arm study was conducted. A total of 239 patients received subcutaneous injections of biosimilar teriparatide 20 μg once a day for a year minimum.

The change in BMD T-score from baseline (pre-treatment) to end of the study (post-treatment) was the main outcome measure. Additionally, the change in the fracture risk assessment tool (FRAX) score was calculated to guess the 10-year probability of major and hip fractures pre- and post-treatment.

Then, a total of 239 patients were included, 27.62%, 14.64%, and 57.74% of which received biosimilar teriparatide for 12-16 months, 17-20 months, and 21-24 months, respectively. The T-score (SD) at the lumbar spine grew from ­–2.67 (1.04) to –2.26 (–1.11) from baseline to the end of the study (mean percent change, 13.07 [–62.89]; 

.001) . Likewise, the T-score at femoral nice grew from ­2.18 (0.87) to –2.09 (0.93; mean percent change, 3.81 [31.52]; 

 = .006). The proportions of patients with maintained or improved BMD T-score at the lumbar spine and femoral next sites were 85.36% and 69.04%, respectively.

Comparable results were acquired in subgroups of patients with rheumatoid arthritis and those with a history of a previous fracture or parental hip fracture. FRAX scores did not significantly change during the study (

 = .551 and .973 at the lumbar spine and femoral neck, respectively).

BMD measurement is the most common tool to measure risk fracture prediction in routine clinical practice, even though patient-reported outcomes give valuable information on the state of health for patients.

“In this study, we demonstrated the effectiveness of one to two years of treatment with the biosimilar teriparatide in patients with osteoporosis. These findings add to the available data for the biosimilar teriparatide and can be used in cost-benefit analyses and healthcare plans,” said the researchers.

Some limitations were present. The primary limitation was the single-arm uncontrolled design of the study. Additionally, researchers were not reporting fracture incidence during the study period.

The findings demonstrated improvements in BMD after treatment with biosimilar teriparatide.

“Our study included a reasonably large number of patients (n = 239) and further increased our understanding of the benefits of this biosimilar agent as a treatment option in patients with osteoporosis and at increased risk for fragility fractures,” concluded the researchers.

Soroush MG, Kheirandish M, Soroosh S. Changes in BMD T-score from pre-to post-treatment with biosimilar teriparatide: a single-arm, multi-center study. Published online May 25, 2023. doi: 10.1016/j.bonr.2023.101689

Articles

Biosimilar teriparatide improves bone mineral density (BMD) when patients with osteoporosis are treated for a year or more.

Biosimilar Teriparatide Improves BMD for Patients With Osteoporosis, Study Finds

The structural, functional, and stability data give convincing evidence of biosimilarity between 

adalimumab-aqvh and the reference product, adalimumab

Adalimumab-aqvh/CHS-1420 (adalimumab-aqvh) was newly approved by the FDA as a biosimilar for adalimumab.

First, this study was conducted to evaluate the analytical similarity of adalimumab-aqvh and the reference product, adalimumab.

Even though adalimumab-aqvh and adalimumab have the same primary structure and sequence, some protein heterogeneity could be anticipated due to the inherent variation that can happen with biologic products are manufactured. Small differences as a result of post-translational modifications might happen during the production of biologics in living cells.

State-of-the-art assays were used to compare the structural, functional, and stability attributes of adalimumab-aqvh and adalimumab.

Scientists are working in a lab with various materials

Then, the primary structure, disulfide structure, glycan profile, secondary and tertiary structures, molar mass, size variants, free thiol, charge variants, hydrophobic variants, post-translational modifications, subvisible particles, host cell proteins, and protein concentration were examined. The functional similarity between adalimumab-aqvh and adalimumab was shown by comparing fragment antigen-binding (Fab)- associated and fragment crystallizable (Fc)- associated biological activities. The stability of adalimumab-aqvh and of adalimumab was contrasted through forced degradation.

The structural qualities of adalimumab-aqvh were indistinguishable to those of adalimumab or met the similarity criteria, with some exceptions. Adalimumab-aqvh and adalimumab showed comparable stability profiles and functional activities. Any perceived differences in the physiochemical attributes did not influence the conclusion of similarity because they did not impact any functional activities related to the adalimumab mechanism of action.

Similarity criteria for adalimumab-aqvh was met for isoelectric point and molecular weight but was not met for protein concentration.

“However, after a process improvement, all subsequent lots were within the similarity range for protein concentration,” added the study authors.

Adalimumab-aqvh did not meet the criteria for percentage main peak by non-reduced capillary electrophoresis in sodium dodecyl sulfate, but the differences seen had no impact on potency or stability.

Still, there were differences in FcγRIIIa binding did not affect similarity in antibody-dependent cell-mediated cytotoxicity

“The differences in FcγRIIIa binding also did not affect the pharmacokinetics or safety of adalimumab-aqvh when evaluated in the clinical trial in which biosimilarity of adalimumab-aqvh to adalimumab was assessed,” said the study authors.

Furthermore, functional characterization using orthogonal assays for known, likely, and plausible mechanisms of action additionally supported similarity between adalimumab-aqvh and adalimumab. Adalimumab-aqvh and adalimumab showed comparable degradation profiles under stressed storage conditions.

“The similarities between adalimumab-aqvh and adalimumab predict similar efficacy and safety outcomes in clinical trials, which was confirmed by the pharmacokinetic, safety, immunogenicity, and efficacy clinical trials that have been conducted,” concluded the study authors.

Jiang Y, Arora T, Klakamp S, et al. Demonstration of physicochemical and functional similarity of biosimilar adalimumab-aqvh to adalimumab. 

. Published online August 26, 2023. Doi:10.1007/s40268-023-00437-3

Data suggest that biosimilarity is demonstrated between reference and biosimilar adalimumab.

Reference and Biosimilar Adalimumab Appear to Share Biosimilarity

Compared with other anti-vascular endothelial growth factor (anti-VEGF) treatments, a ranibizumab biosimilar (RBZ BS) was considered to be the most cost-effective option when used in treat-and-extend (TAE) regimens and pro re nata (PRN) regimens and best societal care (BSC) for patients with 

neovascular age-related macular degeneration (nAMD)

, according to a Japanese societal viewpoint.

 intended to analyze the cost-effectiveness of anti-VEGD therapies, concentrating on the most recent-launched RBZ BS product in patients with nAMD from a Japanese societal viewpoint.

nAMD is the planet’s leading cause of blindness in elderly populations. While anti-VEGF treatments are usually used as first-line treatment for patients with nAMD, they are usually expensive and require repeated injections.

The disease is characterized as a progressive condition that leads to severe visual impairment as age increases. nAMD is considered late-stage AMD. Typical treatments for nAMD are anti-VEGF agents and photodynamic therapy (PDT), but PDT is less commonly used since the start of anti-VEGF therapy with the use of PDT is limited to a special AMD subtype.

A Markov model was created to stimulate the lifetime transitions of a cohort of treatment-naïve patients with nAMD through health states that were established on the involvement of nAMD (single eye vs both eyes), patients’ treatment status, and decimal best-corrected visual acuity. 

The model compared RBZ BS with branded RBZ, aflibercept (AFL), and AFL as loading dose switched to RBZ BS in maintenance in the TAE regimen (RBZ TAE, AFL TAE, and AFL to RBZ BS TAE, respectively), and with branded RBZ in the PRN regimen, and BSC. RBZ BS was better at achieving cost savings compared to RBZ PRN-like TAE regimens and performed better than BSC in PRN regimens.

Data showed that RBZ BS was dominant (higher quality-adjusted life-years [QALYs] and lower total cost) to AFL TAE and AFL to RBZ TAE when TAE regiments were compared. The result was strong regardless of whether the clinical data were taken from the direct head-to-head clinical trial or from indirect treatment comparison. Compared to RBZ TAE, RBZ BS was cost saving. RBZ BS TAE was predicted to be dominant to BSC owing to a lower societal cost.

Of note, the model allowed for the simulation of lifetime transitions of a cohort of patients with nAMD through health states based on involvement of nAMD (single-eye vs both-eye involvement), patients’ treatment status (ie, on or off treatment), and visual impairment severity defined by decimal best corrected visual acuity (BCVA).

Also of note, the magnitude of difference in 2-year treatment frequencies (number of injections) between RBZ (or RBZ BS) TAE and AFL TAE in the indirect comparison study was 5.9 times higher, which seems to be larger than the predicted outcome from real-world practice, as suggested by retrospective observational studies conducted in Japan and other foreign settings.

To the best of the researchers’ knowledge, this is the first study comparing the cost-effectiveness of RBZ BS with present anti-VEGF agents among treatment-naïve patients with nAMD.

The researchers stated that the results of the study need to be interpreted with caution due to some limitations regarding the modelling approach, such as the transition probabilities and treatment frequencies following the third year were assumed to be comparable between RBX and AFL TAE.

This was because of the long-term changes in visual acuity and treatment frequency for these regimens, which weren’t well recorded in the literature. Also, the discontinuation rates for all treatments and treatment regimens were assumed to be the same because these values weren’t available, particularly in the Japanese clinical setting. This could be a strong assumption, as discontinuation rates could vary according to the economic status and treatment types of patients.

“Based on the currently available evidence, our analyses show with a high degree of certainty that RBZ BS can be the most cost-saving treatment option compared with the existing anti-VEGF agents by both TAE and PRN regimens in patients with nAMD from a Japanese societal perspective,” concluded the researchers.

Yanagi Y, Takahashi K, Iida T, et al. Cost-effectiveness analysis of ranibizumab biosimilar for neovascular age-related macular degeneration in Japan. 

. 2023;12(4):2005-2021. doi:10.1007/s40123-023-00715-y

Ranibizumab biosimilar was found to be the most cost-effective for neovascular age-related macular degeneration (nAMD), according to a recent Japanese study.

Study: Ranibizumab Biosimilar Is the Most Cost-Effective Option for nAMD

Here are the top 5 biosimilar articles for the week of August 7th, 2023.

Number 5: Sarfaraz K. Niazi, PhD, gave an overview of the 

, noting why some countries have biosimilars, including follow-on biologics and unbranded biologics, for certain products and why others do not.

 to biologic disease-modifying antirheumatic drugs (bMARDs) in patients with rheumatoid arthritis (RA).

Number 3: Between the launch of 7 adalimumab biosimilars, the release of several market trend reports, and clinical trial results on often ignored disease states, July was a very big month for 

released results from an interchangeability study

 of its adalimumab biosimilar; Express Scripts announced that it will add Cyltezo as well as 2 other adalimumab biosimilars to its formulary list; Anser Therapeutics will offer therapeutic drug monitoring (TDM) for Idacio.

Number 1: Despite global sales for Amjevita (adalimumab-atto) growing by 29% year-over-year and the agent being the 

 on the US market, sales in the United States dropped 63% from the first quarter to the second quarter of 2023.

Here are the top 5 biosimilar articles for the week of August 7, 2023.

The Top 5 Biosimilar Articles for the Week of August 7

Streamlining biosimilar development would permit biosimilar development of more and a wider variety of biological drugs, fast-tracking biosimilar development without impacting patient safety or effectiveness, according to an opinion piece published in 

Patients can still struggle with accessing biological therapies in some markets. There is a need to streamline the biosimilar development process without compromising quality, safety, or efficacy.

This piece—written by 4 prominent voices in the biosimilars space from different pharmaceutical companies—weighs the efficiencies that could be attained within the biosimilar approval process.

Biosimilars have been on the market in the United States since 2015, and Europe since 2005. In that time, biosimilars have become established in the treatment landscape for a wide range of disease, enabling patient access and health care affordability.

The authors recommended multiple changes to streamline biosimilar development straightaway without compromising patient safety or product quality, such as:

Limiting clinical studies to comparative pharmacokinetics (PK)

Using a risk-based approach when evaluating immunogenicity

Eliminating bridging PK studies through acceptance of global comparator reference product

Immediately reconsidering the requirement for multiple-switch studies to obtain US interchangeability designations, and future removal of that category

Updating biosimilar guidelines to reflect more streamlined biosimilar development will create more regulatory certainty and help ensure a sustainable future market for biosimilars that will allow funding in health care budgets for newer medications.

“The proposed steps will expand worldwide access to these increasingly essential medicines in a manner that does not compromise the quality, safety, and efficacy of biologics for any patients, whatever jurisdiction in which they happen to reside,” explained the authors.

 that found that about half of biologic drugs coming off patent in the next decade may have no biosimilar competitors, partially because the market size is too small to warrant the exhorbidant costs and time associated with biosimilar development and clinical trials. Biosimilars can cost as much as $300 million and take up to 9 years to develop.

Additionally, the authors noted that the current regulaotry paradigm is reflective of the time in which it was created, when there was more skepticism around the creation of biosimilars in relation to their reference products. However, new experience and 2 decades worth of data call into question whether the same analyses required in 2005 are needed to prove that a biosimilar has no clinically meaningful differences to the reference product today.

"The potential for increased or different immunogenicity was one of the foremost concerns when the biosimilar development pathway was first developed.... While immunogenicity data should always be collected for both biosimilars and novel biologics, to date, the immunogenicity levels elicited by biosimilars approved by the FDA and European Medicines Agency have reliably matched the immunogenicity of their reference products. This evidence allows the conclusion that potential immunogenicity issues are less of a concern than initially conjectured."

Despite the availability of increased biosimilar access and lowering health care costs, many patients who could benefit from biologics struggle to get opportune and inexpensive access, especially in areas like the United States and lower- and middle-income countries, where access is even more limited.

Immunogenicity evidence allows the conclusion that possible immunogenicity problems are less of a concern than first thought. There are opportunities to revise the present biosimilar development paradigm to increase the efficiency of future biosimilar development by applying current science and already obtained experience with the development and marketing of biosimilars to date.

Ultimately, the authors suggest that immunogenicity analysis biosimilars be moved to a risk-based consideration as opposed to a global and routine necessity.

Comparative efficacy studies lack validity because no human clinical studies should be conducted unless meaningful new information can be gained, and this experience can be adapted into revised regulatory practice.

In general, experience to date suggests that a more targeted approach to the inclusion of clinical efficacy studies in biosimilar approval applications is needed. Certainly, regulators with extensive biosimilar experience have suggested reducing some routine requirements for comparative clinical efficacy studies.

The authors emphasized that, given the collective experience of all stakeholders, it’s time to reconsider the routine expectation for a comparative efficacy study when developing a biosimilar. Conducting additional and unnecessary clinical studies suspends biosimilar development and increases development costs, both will inevitably have a negative impact on access. Separating studies for regulatory decision-making purposes from those for stakeholder education is vital.

They also recommend that for optimal pharmacovigilance, it is vital to pinpoint not just the brand name or the nonproprietary name, but also the batch number. Growing the quality of pharmacovigilance is important for all drugs and in all regions to facilitate safety assessment after introduction into the marketplace.

It is unlikely that real-world evidence will replace detailed analytical comparisons or PK clinical studies when developing a preapproval data package to support licensure of a biosimilar. However, as the use of real-world evidence grows in regulatory decision-making actions for originator biologic approvals, its value for biosimilars may be important to also consider.

"The opportunity to streamline biosimilar development has been recognized by multiple stakeholders. Concurrently, demands for access to biologics at more affordable prices are likely to increase in all regions, both developed and emerging. Viable competition in all regions can only occur and be sustainable if biosimilars can be developed and manufactured more efficiently."

Cohen HP, Turner M., McCabe D, Woollett GR

 Future evolution of biosimilar development by application of current science and available evidence: the developer’s perspective. 

. Published online August 5, 2023. doi:10.1007/s40259-023-00619-0

Streamlining biosimilar development would permit biosimilar development of more and a wider variety of biological drugs, fast-tracking biosimilar development without impacting patient safety or effectiveness, according to an opinion piece.

Authors Suggest Major Policy Shifts to Boost Biosimilar Development, Accessibility

On this episode, we’re giving a rundown of some of the biggest stories in the immunology space regarding biosimilars, like the launch of 7 adalimumab biosimilars, the release of multiple market trend reports, and clinical trial results on traditionally bypassed disease states.

First Round of Adalimumab Biosimilar Launches in July

Celltrion Launches Yuflyma on the US Market

US Welcomes Idacio, Hulio to the Adalimumab Biosimilar Market

Will the Entry of Adalimumab Biosimilars to the US Market Successfully Lower Spending?

Contributor: Self-Administered Biosimilars Are Coming Quickly—Is Your Clinic Ready?

Despite Steep Discounts, Humira Biosimilars Are Priced More Than Original Originator Price

Price Reductions of TNF Inhibitors Across Europe After First and Second Biosimilar Launches

Multiple Infliximab Biosimilar Switches Were Safe, Effective

Adalimumab Biosimilar Improved Symptoms for up to 48 Weeks in Ankylosing Spondylitis

Biosimilar, Innovator Romiplostim Comparably Safe and Effective

Podcasts

Biosimilars Immunology Roundup for July 2023—Podcast Edition

Here are the top 5 biosimilar articles for the week of July 31st, 2023.

Number 5: Reference bevacizumab and proposed biosimilar (BAT1706) demonstrated 

, market share, and utilization of the tumor necrosis factor (TNF)–α inhibitors infliximab, etanercept, and adalimumab as the first and second biosimilars for each molecule were introduced in Europe.

 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.

 for their aflibercept biosimilars; the European Medicines Agency accepted a marketing authorization application for an ustekinumab biosimilar; and Roche filed suit against Biogen over a tocilizumab biosimilar.

Number 1: In a real-world study in India, patients with ankylosing spondylitis who were treated with the adalimumab biosimilar Exemptia for 10 weeks 

 activity that persisted through 48 weeks.

Here are the top 5 biosimilar articles for the week of July 31, 2023.

The Top 5 Biosimilar Articles for the Week of July 31

An association between antidrug antibodies and nonresponse to biologic disease-modifying antirheumatic drugs (bMARDs) in patients with 

 is insinuated in a prospective cohort study, according to 

Monitoring antidrug antibodies could be contemplated in the treatment of these patients, especially nonresponders to biologic RA drugs. Conflicting data exist on the association of bDMARDs in RA. The researchers’ objective was to analyze the link of antidrug antibodies with response to treatment for RA.

bDMARDs are often initiated as a second-line treatment for RA. But the retention rate is low, with only 40% to 60% of patients maintaining treatment after 2 years.

“There is still debate regarding the adverse clinical implications of antidrug antibodies for the response to treatment, which has been clearly demonstrated only for adalimumab ,” emphasized the authors.

This was a cohort study that analyzed data from the Anti-Biopharmaceutical Immunization: Prediction and Analysis of Clinical Relevance to Minimize the Risk of Immunization in Rheumatoid Arthritis Patients (ABI-RA) multicentric, open, prospective study of patients with RA from 27 recruiting centers in 4 European countries consisting of France, Italy, the Netherlands, and the United Kingdom. Eligible patients were aged 18 or older, had an RA diagnosis, and were starting a new bDMARD. Recruitment stretched from March 3, 2014, to June 21, 2016. The study reached completion in June 2018, and data were analyzed in June 2022.

Patients were treated with a novel bDMARD: adalimumab, infliximab (grouped as anti-tumor necrosis factor [TNF] monoclonal antibodies [mAbs]), etanercept, tocilizumab, and rituximab, according to the decision of the treating physician.

The primary outcome of this study was the link of antidrug antibody positivity with the European Alliance of Associations for Rheumatology (EULAR) response to treatment at month 12. The secondary end points were the EULAR response at month 6 and visits from month 6 to months 15 to 18. 

Out of the 254 patients recruited, 230 (mean [SD] age, 54.3 [13.7] years; females, n = 177) were evaluated. Antidrug antibody positivity was 38.2% in patients who were treated with anti-TNF mAbs, 6.1% with etanercept, 50.0% with rituximab, and 20.0% with tocilizumab at month 12.

There was an inverse link between antidrug antibody positivity (odds ratio [OR], 0.19; 95% CI, 0.09-0.38; 

 < .001) aimed against all biologic drugs and EULAR response at month 12. Evaluating all the visits starting at month 6 using generalized estimating equation models confirmed the inverse link between antidrug antibody positivity and EULAR response (OR, 0.35; 95% CI, 0.18-0.65; 

There was a significantly higher drug concentration of anti-TNF mAbs in patients with antidrug antibody-negative vs antidrug antibody-positive status (mean difference, −9.6 mg/L; 

 < .001). Drug concentrations of etanercept (mean difference , 0.70 mg/L; 

 = .005) and adalimumab (mean difference, 1.8 mg/L; 

 = .01) were worse in nonresponders vs responders. Methotrexate comedication at baseline was inversely linked with antidrug antibodies (OR, 0.50; 95% CI, 0.25-1.00; 

In the current study, no association was found between the observed anti-rituximab antidrug antibodies and treatment response. Also, the study confirmed the high incidence of antidrug antibodies against multiple bDMARDs and the inverse link of antidrug antibodies with EULAR response.

Moreover, this study emphasized the association between antidrug antibodies and lower drug concentration of anti-TNF mAbs and lower concentration with nonresponse of adalimumab and etanercept.

Using the GEE model, an inverse association was shown for the first time between antidrug antibodies directed against tocilizumab and treatment response. These antibodies weren’t as prevalent than those against anti-TNF mAbs, but in the 20% of patients with antidrug antibody-positive status who were treated with tocilizumab, the antibodies were linked with treatment response.

The current study discovered an inverse association between antidrug antibodies against 3 bDMARDs and response to treatment. Even though the study did not find a definitive role for therapeutic drug monitoring, it provided arguments for an inverse association between clinical outcome and the presence of antidrug antibodies. The inverse association between methotrexate at baseline and the presence of antidrug antibodies against bDMARDs was also confirmed.

This study had some limitations, including that the study was not powered to show a link for each drug class. Despite this, the ORs in all analyses with individual drug classes displayed similar results or patterns.

“Monitoring of antidrug antibodies could be considered in the personalized management of patients with RA, particularly nonresponders,” concluded the authors.

Bitoun S, Hässler S, Ternant D, et al. Response to biologic drugs in patients with rheumatoid arthritis and antidrug antibodies. 

 Published online July 12, 2023. doi:10.1001/jamanetworkopen.2023.23098

A link is suggested between antidrug antibodies and nonresponse to biologic disease-modifying antirheumatic drugs (bMARDs) in patients with rheumatoid arthritis (RA).

Link Between Antidrug Antibodies, Nonresponse to bMARDs in Patients With RA

Here are the top 5 biosimilar articles for the week of July 24th, 2023.

price of Humira (reference adalimumab) has risen

 so dramatically over time that the list prices for new adalimumab biosimilars are now significantly higher than the original price of the originator, according to a report contextualizing net prices of adalimumab and the role of rebates.

Number 4: The Center for Biosimilars® provided an 

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.

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

Samsung Bioepis’ Biosimilar Market Report

 showed a strong correlation between biosimilar usage and decreased drug prices, proving that biosimilars are delivering on the promise of savings and price erosion.

Number 1: Sarfaraz K. Niazi, PhD, detailed his efforts to 

 to draft legislation that would remove interchangeability requirements and animal toxicology studies for biosimilars.

Here are the top 5 biosimilar articles for the week of July 24, 2023.