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WHEN CHOICE ARRIVES: Competition & Consequences

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BIOSIMILAR APPROVALS

Cameron Santoro is an associate editor for The Center for Biosimilars

Videos

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

The Top 5 Biosimilar Articles for the Week of July 22

Articles

Projected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.

Budget Impact Analysis of Biosimilar Natalizumab in the US

A biosimilar dulaglutide showed similar pharmacokinetic and safety profiles compared with the reference product Trulicity in healthy Chinese participants, according to a phase 1 analysis.

Phase 1 Study Shows Promise for Dulaglutide Biosimilar

Boehringer Ingelheim (BI) partners with GoodRx to offer its unbranded adalimumab biosimilar to patients at an exclusive low price; a new ustekinumab biosimilar launches in Europe; and Mexican officials approve a bevacizumab biosimilar.

Eye on Pharma: BI Cyltezo Partnership; Europe Ustekinumab Launch; Mexico Biosimilar Approval

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Regulatory

1rem

Gillian Woollett, MA, DPhil, is the the vice president and head of regulatory strategy and policy at Samsung Bioepis. Prior to her work at Samsung Bioepis, she served as Avalere Health's senior vice president for over 10 years.

The legal and common uses of “interchangeability” continue to be conflated.

Confusion Persists Around the Interchangeability Designation for Biosimilars

As more biosimilars are granted interchangeability status, 2 representatives from Samsung Bioepis stop misinformation in its tracks by clarifying that the designation will primarily impact pharmacy dispensing instead of prescription habits.

Contributor: Interchangeability Is a Dispensing Issue, Not a Prescribing One

Boehringer Ingelheim (BI) partnered with GoodRx to offer its unbranded adalimumab biosimilar to patients at an exclusive low price; a new ustekinumab biosimilar launched in Europe; and Mexican officials approved a bevacizumab biosimilar.

 a patient affordability initiative to provide BI’s citrate-free unbranded biosimilar adalimumab-adbm, which references Humira (adalimumab), at a low cash price exclusively on GoodRx.

 This FDA-approved biosimilar treats autoimmune conditions like rheumatoid arthritis, juvenile idiopathic arthritis, ulcerative colitis, and Crohn disease. The partnership aims to enhance access and affordability for this high-cost medication. The biosimilar is an unbranded version of Cyltezo (adalimumab-adbm).

Starting July 18, the program offers high- and low-concentration formulations of adalimumab-adbm as prefilled syringes or autoinjectors at $550 per 2-pack, a 92% discount from Humira's list price. This initiative allows anyone with a valid prescription to purchase the drug at over 70,000 retail pharmacies nationwide, regardless of insurance status, potentially speeding up therapy access for patients.

"Patients with certain chronic inflammatory diseases who do not have insurance or are underinsured may not be able to afford essential biologic medicines, including biosimilars, to treat their disease," said Chris Marsh, senior vice president of value and access at Boehringer Ingelheim. "Partnering with GoodRx to offer our biosimilar adalimumab-adbm at a low price to these patients helps us deliver on our commitment to lowering financial barriers and improving access to critical treatments."

 as 1 of 10 adalimumab biosimilars to launch that year. Cyltezo was the first adalimumab biosimilar to be approved with an interchangeability designation and is available in both a citrate-free 

 formulation and a low-concentration formulation.

Ustekinumab Biosimilar Launches in Europe

 Uzpruvo, the first approved ustekinumab biosimilar in Europe, across major European markets following the expiry of the reference molecule (Stelara) patent.

 Uzpruvo is indicated for Crohn disease, psoriatic arthritis, and plaque psoriasis. It features a thinner needle compared with the reference product and is latex-free to minimize allergic reactions. The companies noted that the biosimilar, developed and manufactured entirely in Europe, has a 36-month shelf life.

“With comparable safety, efficacy and immunogenicity, Uzpruvo gives clinicians an opportunity for a seamless and simple switch for their patients, who can benefit from a thinner needle and latex-free syringe,” commented STADA’s global specialty head, Bryan Kim. “Physicians and patients can have full confidence that STADA has more than 15 years of experience in enhancing patient access through high-quality biosimilars in Europe, having launched our first biosimilar in 2008.”

Uzpruvo is STADA’s seventh biosimilar in Europe, complementing its offerings in bone health, nephrology, oncology, and ophthalmology. Alvotech, a global leader in biosimilars, has a portfolio of 11 biosimilars and has launched the Stelara biosimilar in Canada, Japan, and now Europe.

 from Mexico’s COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) to market Bhava, a bevacizumab biosimilar for various cancers.

 Bhava will be available in 100 mg/4 mL and 400 mg/16 mL strengths. Zydus initially launched this biosimilar in India in 2015 as Bryxta, with about 50,000 patients receiving the biosimilar since launch.

As of July 23, 2024, Zydus Lifesciences' shares were trading at $13.74, down 0.39% from the previous close but have gained 87% in the past year.

The FDA recently issued 2 observations about Zydus's transdermal manufacturing site, which the company is addressing. Formerly known as Cadila Healthcare Limited, Zydus is a prominent Indian pharmaceutical company.

1. Boehringer Ingelheim and GoodRx announce exclusive patient affordability initiative for Adalimumab-adbm injection, Boehringer's biosimilar to Humira®. Boehringer Ingelheim. Press release. July 18, 2024. Accessed July 22, 2024. 

https://www.prnewswire.com/news-releases/boehringer-ingelheim-and-goodrx-announce-exclusive-patient-affordability-initiative-for-adalimumab-adbm-injection-boehringers-biosimilar-to-humira-302199865.html

2. STADA and Alvotech launch Uzpruvo, the first approved ustekinumab biosimilar to Stelara, across Europe. Avotech. Press release. July 22, 2024. Accessed July 23, 2024. 

https://investors.alvotech.com/news-releases/news-release-details/stada-and-alvotech-launch-uzpruvo-first-approved-ustekinumab

3. Zydus secures COFEPRIS approval for Bhava biosimilar in Mexico. IIFL Securities. July 23, 2024. Accessed July 23, 2024. 

https://www.indiainfoline.com/news/business/zydus-secures-cofepris-approval-for-bhava-biosimilar-in-mexico

Business & Practice

Clinical

 Wyost/Jubbonti (denosumab-bddz; GP2411), the first biosimilar to reference Xgeva/Prolia (denosumab) in the US.

 The drugs will be used to treat osteoporosis and hypercalcemia as well as prevent skeletal-related events associated with bone metastases from solid tumors.

The FDA accepted Sandoz’ biologics license application for Wyost/Jubbonti in 

. This approval is also notable in that there are currently no denosumab biosimilars approved in the European Union. The news comes after the same products were approved in Canada 

Similar to the reference products, the biosimilars have the same drug compound (denosumab-bddz) but were approved with 2 brand names that will be used for different indications:

Wyost vs Jubbonti

Jubbonti is interchangeable with Prolia, and Wyost is interchangeable with Xgeva.

Wyost and Jubbonti were also approved with interchangeability designations, allowing them to be substituted for their respective reference product at the pharmacy level without needing to wait for a provider to give permission. It is the ninth biosimilar to receive this label.

"Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events, which are disease states that can profoundly reduce quality of life for patients. I am proud that Sandoz continues to pioneer access to these life-changing medicines for the patients who need them most," commented Keren Haruvi, President Sandoz North America, in a statement.

According to Sandoz, over 10 million adults over age 50 in the US have osteoporosis, of whom most (> 80%) are women. It is predicted that 1 in 2 women and 1 in 4 men will experience an osteoporosis-related fracture in their lifetime, which could result in decreased quality of life, disability, and death.

The approval of Wyost/Jubbonti was based on a comprehensive data package containing 

 results that were presented at the American Society of Clinical Oncology annual meeting 2023 and the American Society for Bone and Mineral Research annual meeting 2023, respectively.

Denosumab products are human monoclonal antibodies that bind to the RANKL protein, preventing activation of the RANK receptor on the surface of osteoclasts and preventing osteoclastic bone resorption.

The phase 1 study evaluated the pharmacokinetics (PK) and pharmacodynamics (PD) of denosumab-bddz compared with the reference product (EU authorized and US licensed) in 499 healthy participants (mean [SD] age, 64.6 [6.1] years; White, 90.9%).

 The double-blind, 3-arm, parallel-group analysis was conducted at 2 German centers. Participants were randomized 1:1:1 to receive the biosimilar or the EU- or US-sourced reference agents.

Participants were between 28 and 65 years old and weighed between 50 and 90 kg. PK end points were measured by area under the serum concentration-time curve measured from the time of dosing and extrapolated to infinity (AUC

), or to the last measurable concentration (AUC

), and maximum observed serum concentration (C

). PD end points were measured by the area under the effect-time curve of the percentage change from baseline (AUEC %CfB) in serum carboxy-terminal crosslinked telopeptide of type I collagen (CTX) and CTX and procollagen I N-terminal propeptide (PINP) serum concentration per visit.

Results showed that the treatment arms (biosimilar vs EU-sourced reference product; biosimilar vs US-sourced reference product) showed statistically similar values for AUC

 (1.02; 1.00), and AUEC %CfB in CTX (1.01; 1.01). Changes from baseline to Week 39 in serum concentrations of CTX and PINP were also similar between groups.

The international, double-blind, parallel group phase 3 trial (ROSALIA study; 

) looked at the clinical efficacy, safety, and tolerability of denosumab-bddz compared with the reference product through 52 and 78 weeks.

 Postmenopausal women with osteoporosis aged 55 to 80 years who had bone mineral density (BMD) T-scores between 2.5 and 4.0 at the lumbar spine were eligible for participation.

In total, 527 patients were randomized 1:1 to receive a 60-mg dose of Wyost or the EU-authorized reference product on day 1 and at week 26. Prior to the third dose at week 52, patients who were receiving the reference product were rerandomized to remain on the reference product or switch to the biosimilar.

Overall, 502 patients received a third dose (biosimilar to biosimilar, n = 253; reference to reference, n = 125; reference to biosimilar, n = 124). The mean age of the participants was 64.6 (6.15) years, and most (91.3%) were White.

No clinically meaningful differences between the groups regarding new vertebral fractures were observed. Switching from the reference product to the biosimilar did not affect the incidence or severity of treatment-emergent adverse events (TEAEs). Immunogenicity profiles were similar between groups.

Most TEAEs were grade 1 or 2, most of which were not considered treatment related, and no treatment discontinuations occurred as a result. The most common TEAEs reported were hypocalcemia, COVID-19 infection, and nasopharyngitis.

The majority of antidrug antibodies had very low, nonreportable titers (< 20 mg/mL), were nonneutralizing, and transient.

In its company statement, Sandoz declined to comment on a launch timeline due to ongoing litigation issues with the reference product manufacturer (Amgen).

I think they are excited for these biosimilars to come to market and are ready to prescribe them to patients.

I think they will wait for more real-world data with these products before prescribing them.

I think they will need more education on the safety and efficacy on these products before feeling comfortable prescribing them.

Sandoz receives FDA approval for first and only denosumab biosimilars. News release. Sandoz; March 5, 2024. Accessed March 5, 2024. 

https://www.marketscreener.com/quote/stock/SANDOZ-GROUP-AG-160016887/news/Sandoz-receives-FDA-approval-for-first-and-only-denosumab-biosimilars-46097288/

2. Vogg B, Poetzl J, El Galta R, Fuhr R, Schwebig A, Sekhar S. Pharmacokinetics and pharmacodynamics of proposed denosumab biosimilar and reference denosumab in healthy male subjects. Presented at: 2023 ASCO Annual Meeting; June 2-6, 2023; Chicago, IL. Poster SAT-436.

3. Jeka S, Dokoupilová E, Kivitz A, et al. Pharmacokinetics and pharmacodynamics of proposed denosumab biosimilar and reference denosumab in postmenopausal osteoporosis: the ROSALIA study. Presented at: ASBMR 2023 Annual Meeting; October 13-16, 2023; Vancouver, Canada. Poster P303.

Sandoz’ Wyost/Jubbonti (denosumab-bddz) references Prolia and Xgeva and can be used to treat osteoporosis and hypercalcemia as well as prevent skeletal-related events associated with bone metastases from solid tumors.

Approvals Launches

FDA Approves First Denosumab Biosimilars

A broader selection of biosimilars for each drug category

Improved physician training on biosimilar equivalence

Step therapy policies that promote the use of economical therapies

Mandatory biologics pricing disclosures by health plans

Opinions are diverse on how best to clear the obstructions to biosimilar market entry and patient access. 

Polls

Poll: What Is the Best Way to Improve Biosimilar Access?

Jeffrey Casberg, RPh, MS. 

Jeffrey Casberg, RPh, MS, senior vice president of pharmacy at 

 mentions several drugs due to lose patent exclusivity soon, which would allow generic versions to be produced. Casberg discusses biosimilar competition, a relatively new phenomenon in the pharmaceutical industry that could lead to significant price reductions.

He highlighted various types of medications, ranging from oncology treatments, to diabetes, inflammatory diseases, and age-related macular degeneration. Casberg suggests stakeholders remain vigilant of these patent expirations in the upcoming year or couple of years as he and other experts work to analyze and determine drug life cycle insights to predict future market shifts.

With brand patents expiring, which products about to face upcoming generic and biosimilar competition do you think stakeholders should be keeping their eye on?

Yeah, there are a couple products coming down the road that would be losing exclusivity. The first one I'll hit is 

 [liraglutide], it's a GLP-1 [inhibitor]. You can't talk about pharmaceuticals today without talking about GLP-1 [inhibitors] and weight loss.

So, Victoza was kind of a big advance back in its day. It was the first once daily GLP-1 [inhibitor], once daily subcutaneous administered injectable product. It has less nausea associated with it than its previous predecessor, 

 [exenatide]. It was also the first GLP-1 [inhibitor] that had cardiovascular positive studies for cardiovascular effect. Great drug but I don't see it really helping with this whole GLP-1 [inhibitor] shortage and weight loss issue.

 [dulaglutide], they both have about 50% the weight loss that 

 [tirzepatide] have so I don't see all of a sudden a big rush to go to Victoza generic because number 1: it's once a day, and number 2: it doesn't have the weight loss that some of the big products that you're hearing about every day have. So, that's Victoza, that'll be coming shortly here in June. I think there could be quite a few generics.

 [dasatinib]. They're both tyrosine kinase inhibitors similar to 

 [imatinib mesylate], great drugs in oncology, pretty expensive therapies, and we should get quite a few generics and a good amount of price reduction there.

Then moving over to the biosimilars side, 

 [ustekinumab] biosimilars are coming. Everybody's been talking about 

 [adalimumab] and 9 or 10 companies bringing those [biosimilars] to market but almost just as big, Stelara is a big drug—$15 to $20 billion product—and it also has 8 or 9 manufacturers lined up to bring products to market. We'll have to see if the adoption by payers is similar or quicker, we're just starting to have some success and conversion of Humira to biosimilars. We'll have to see how the payers adopts Stelara [biosimilars]. Maybe they've gained some more confidence and learned a little bit from the Humira introduction. We'll have to see and Stelara will be coming early in 2025. Amgen has the first product out but then pretty quickly thereafter, several other products will hit.

 [aflibercept] biosimilars in the ophthalmology area, for age-related macular degeneration. We had 

 [ranibizumab] biosimilars come out with a couple of biosimilars recently and those biosimilars have done pretty well.

Eylea, we're watching, we don't know if it's going to come out this year, or in a year or 2. There's an opportunity this year, but IPD, the company I work for does a lot of predicting of this and we think it actually may not be in 2024, it might be 2025 or 2026 before we get Eylea, but watch for that. I had mentioned Victoza, Trulicity is a $16 billion GLP-1 [inhibitor], and it's biosimilar [could be] out in 2027. Something to plan for by the payers.

Jeffrey Casberg, RPh, MS, examines upcoming generic and biosimilar competition in the pharmaceutical industry, showcasing certain drugs that will face competition soon. 

Jeffrey Casberg Predicts Generic, Biosimilar Competition in the Pharmaceutical Market

IDP Analytics SVP Says IRA, PBM Legislature Reshape US Drug Costs

In an interview with Jeffrey Casberg, RPh, MS, senior vice president of pharmacy at 

, discussed policy changes and market forces that are impacting the cost of drugs. Casberg explained why he felt the Inflation Reduction Act (IRA) and pharmacy benefit manager (PBM) legislation are the most impactful.

He also touched on value-based pricing models. Although skeptical of value-based pricing being a universal solution, Casberg sees promise in its use for expensive drugs, like gene therapies, where outcomes can be more easily measured.

This transcript has been lightly edited for clarity. 

Do you foresee any policy changes or market forces that could significantly alter the cost landscape for both branded and generic drugs in the near future?

So policy or legislation, everything is about politics. I guess I'll mention 2 things. I'll mention the 

. Those would be the 2 hot ones on the IRA side, we just had the first release of the negotiated drugs and which drugs they are. We'll be getting 

, a new acronym for drug pricing, those will be announced coming up soon.

We're going to have the out-of-pocket cost of Part D reduced to the max of an out-of-pocket cost to $2,000. That's big for patients, impactful to manufacturers, and payers. Now they're going to have to deal with different benefit designs and how they're going to market the drug and price the drug or how payers are going to make the benefits work with the new $2,000 max, so there is something for everybody there.

Then 2025 redesign, for the Inflation Reduction Act, there's also quite a few different benefit designs changing for 2025. There's 

 so the manufacturers have to watch how much they're raising the prices of their drugs. If they go up too high, too quickly, then they get these penalties against them. The IRA has a number of different things, pretty complex, and everybody's paying attention to that.

Then on the second hand, it would be PBM legislation. I guess it depends on who you are and your feeling towards PBM legislation. I think it probably just comes down to more transparency. Every business has to make money and PBMs have done it. Somebody could argue they did it okay. Some say it was all smoke and mirrors but I think there's legislation now to have more transparency on PBMs. We'll see how that rolls out but a lot of discussion up in Washington on that these days.

Value-based pricing models are increasingly being explored. How do you think value-based pricing will impact the development, approval, and access to new drugs?

So value-based pricing, you hear a lot about it. You hear people trying to implement it, manufacturers bring proposals to payers on value-based pricing models. What we don't hear of are the results and if they are working or not.

I don't know in the long run, if value-based pricing will be the 'be all and end all' and change the way drugs are paid for in the United States. I'm going to say no but I think there's some value to value-based pricing and in how you look at drugs and evaluate them.

I think especially some of these high cost therapies have opportunities for some value-based models. As I was saying earlier, there's more and more of these high cost, really expensive products and looking at outcomes and measuring outcomes, that kind of thing are for these gene therapies and other expensive therapies.

I'm not saying value-based pricing will take over but I think there's opportunity in the future for use of them.

Jeffrey Casberg, RPh, MS, from IPD Analytics, explains why he believes policy changes and market forces are impacting the cost of drugs, including the Inflation Reduction Act (IRA) and pharmacy benefit manager (PBM) legislation.

IPD Analytics' Jeffrey Casberg Says IRA, PBM Legislation Reshape US Drug Costs

Jeffrey Casberg Q3

Jeffrey Casberg, RPh, MS, senior vice president of pharmacy at 

, considers the top 3 promising biosimilars currently coming down the pipeline. He addresses the significance  of each and the specific areas of health they treat.

He also touches on the FDA Advisory Committee and speaks about the obstacles that have delayed approvals for these medications.

This transcript has been lightly edited for clarity.

In your view, what are the top 3 promising specialty drugs currently coming down the pipeline and why should stakeholders be keeping an eye on them?

The first one I'll talk about is donanemab for Alzheimer's disease by 

; it's an amyloid-β inhibitor for early Alzheimer's disease. It would be a little bit different than 

 from Biogen, which was fully approved more recently.

Donanemab was originally going to be approved beginning of 2023, so over a year ago, but it has had a little bit of a storied pathway to approval. We were watching for an approval here any day during this last month or so, then out of the blue, there was an announcement that the FDA has requested an 

If I'm a manufacturer, not really happy about that; you never really want extra scrutiny on your drug. I'm sure they're going to talk about the dosing regimen, the potential for shorter duration of therapy compared to Leqembi probably the ARIA [amyloid-related imaging abnormalities] side effect profile. They haven't given us a date for that FDA Advisory Committee meeting. I would anticipate a date being announced any day and I still think there's opportunity for approval before the end of 2024.

I think one of the other products that is exciting is resmetirom, or Rezdiffra. for NASH [nonalcoholic steatohepatitis]. First product approved for NASH. Again, a therapeutic area we've been waiting for therapies now for maybe 10 years. Finally we do have an approval. Congratulations to 

 on that, getting their product over the finish line.

A once daily, oral product. It showed signs of efficacy and NASH resolution and fibrosis improvement. Prescribing information did not include discussion of the need for biopsy in diagnosis. So, to diagnose NASH, now called MASH [metabolic dysfunction-associated steatohepatitis], the gold standard is liver biopsy, but that's pretty invasive. You can also use noninvasive therapy testing to get diagnosis of staging of NASH in the liver. They did not have that, which was a plus for Madrigal.

It would be interesting to see how the payers set up their criteria for approval. There's a whole lot of population out there that could be treated with this, so that's another big approval that just occurred. 

I'll just mention one other recent approval. It's called 

 for pulmonary arterial hypertension, sotatercept, by Merck. Winrevair is the brand name.

It's a new product for PAH, pulmonary arterial hypertension. It's a new mechanism of action, and has the potential to be more disease modifying—the other therapies out there are more symptomatic treatments—and probably early on will be used as add-on or [in the] second or third line. But I think as physicians get used to it, they could move it up in therapy.

In an interview with Jeffrey Casberg, MS, RPh, he discusses 3 promising specialty drugs coming through the pipeline. Casberg explains these drugs offer new treatment options for major diseases and stakeholders should watch for their potential impact on the market.

Gillian Woollett, MA, DPhil

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