Launch Of Biosimilars Research Articles

US Commercial Plans Increase Choice Of Biosimilar And Originator Products; Market Net Prices Decrease.

Biosimilars drugs are almost identical copies of original biologic products. Early biosimilars had slower adoption and savings than expected; however, biosimilars launched in recent years have had more success. With several biosimilar launches planned in the next few years, it is important to understand how the state of the market might foretell significant market savings in the future. To do so, we explored how the introduction of biosimilars affected originator-biosimilar markets during the period 2017-22. We found that after biosimilar availability, payers increasingly allowed choice of preferred products. By 2022, 76percent of commercial payers' coverage policies listed two or more products (originator or biosimilar) as first-line options. Biosimilar market shares exceeded those of originators a mean of three years after first biosimilar launch, and originator-biosimilar market average sales price declined substantially. Taken together, these findings provide evidence of a functioning competitive market.

Budget impact analysis of including biosimilar adalimumab on formulary: A United States payer perspective.

The biosimilar market is growing rapidly, as evidenced by 41 approvals and 37 launches to date. As adalimumab biosimilars launch in the United States, competition among biosimilar and reference adalimumab will likely increase across multiple reference indications, including rheumatology, dermatology, and gastrointestinal diseases, which may lead to decreased payer costs. To evaluate the costs of adding biosimilar adalimumab to a US commercial plan by exploring various utilization and price differential scenarios. A 3-year budget impact model for a US commercial plan of 1 million people was developed to assess switching from reference adalimumab or any self-injectable reference tumor necrosis factor (TNF) inhibitor to biosimilar adalimumab. Pharmacy and medical costs were analyzed through high- and low-conversion scenarios from reference adalimumab and the TNF inhibitor class. Price reductions of 5% to 60% relative to reference adalimumab based on previous biosimilar launches were also explored. Short-term medical costs were evaluated as additional simple and complex office visits, with scenarios of half of switch patients having 1 visit up to all switch patients having 10 visits. In a target population of 1,863 patients, switching from reference adalimumab to biosimilar adalimumab had cumulative cost savings of $5,756,073 with slow conversion (10%-20% over 3 years) and $28,780,365 with fast conversion (50%-100% over 3 years). Similar results were seen when switching from any other self-injectable reference TNF inhibitor. Cost savings more than $1 million were seen with a 10% conversion from reference adalimumab and a 15% price reduction from reference adalimumab. Additional office visit scenarios had a negligible impact on budget, with no changes in per-member-per-month costs until all switch patients had 10 additional complex visits, in which per-member-per-month costs increased by $0.02. In a hypothetical plan of 1 million lives, use of biosimilar adalimumab in commercial plans can lead to significant cost savings for payers because of increased competition. Greater and faster biosimilar conversion rates from reference adalimumab and other reference TNF inhibitors resulted in decreased costs. Additionally, even with short-term medical expenditures, cost savings were still realized when switching to biosimilar adalimumab.

New biosimilar launches to compete against blockbuster drug Humira

New biosimilar launches to compete against blockbuster drug Humira

POSC223 Realising the Full Potential of Benefit-Sharing Programs Established to Promote the Cost-Effective Prescribing of Biologics: A European Comparative Analysis of Implementation Challenges

The market launch of biosimilars may induce price competition and allows selecting the most cost-effective option from a range of therapeutically equivalent biologics. Hence, payers across Europe have experimented with benefit-sharing programs, which are incentive schemes established through the collaboration of stakeholders (e.g., health authorities/payers, hospital administrators, and healthcare professionals) to support the use of the most cost-effective biologics and to share resulting savings among stakeholders involved.

Penetration rate of anti-TNF biosimilars and savings at 5 years after their introduction in French hospitals

Since the expiry of the patents on originator anti-TNF agents in Europe, France has authorized the sale of biosimilars. The penetration rate of anti-TNF agents and their biosimilars, and the cost savings driven by the introduction of biosimilars appears to vary widely. This study aimed to describe the market share of anti-TNFs and their biosimilars, and the cost savings generated by the introduction of biosimilars in French hospitals 5 years ago. The pharmaceutical component of the French national uniform hospital discharge data set database (PMSI) was used to study sales of infliximab, etanercept and adalimumab originators and biosimilars, and to estimate cost savings generated by the introduction of biosimilars onto the market, using the historical tariffs of the originators. The penetration rate of anti-TNF biosimilars in France in 76% for infliximab, 74% for etanercept and 77% for adalimumab. In 2020, Inflectra® (41%) was the Remicade® biosimilar with the highest sales volume, while Erelzi® (57%) and Amgevita® (64%) were the most widely sold biosimilars of Enbrel® and Humira® respectively. In terms of cost savings since the launch of biosimilars, overall, for all biosimilars taken together, over the 5-year period, a total of 824 million Euro was saved, in relation to the historical tariffs of the originators. This study shows firstly that the penetration rate of anti-TNF biosimilars in France 5 years after their launch is close to 80%. Secondly, we show that the cost savings generated by the use of biosimilars to anti-TNF agents exceed 820 million Euro over 5 years.

Competition From Biosimilars Drives Price Reductions For Biologics In The French Single-Payer Health System.

France has a single-payer health insurance system that has the authority to impose pharmaceutical price reductions but relies on decentralized market negotiations between hospitals and manufacturers to establish prices for injected and infused biologics. Hospitals rely on biosimilars-less expensive but therapeutically equivalent variants of biologic medications-to stimulate competition. Price reductions negotiated by hospitals subsequently are adopted by the health insurance system, driving hospitals to negotiate a new round of discounts. This article measures 2004-20 trends in prices, price reductions, utilization, and market shares for three prominent biologics-Remicade, Enbrel, and Humira-and their eleven competing biosimilars. Biosimilar launches are associated with a sequence of price reductions for the reference biologic, for other biologics that treat similar conditions, and for all related biosimilars. The French experience provides lessons for the US in its efforts to use competition from biosimilars to drive price reductions and savings from biologics.

Real-world trends in biosimilar prescribing among oncology providers, 2019-2021.

e18701 Background: The number of approved biosimilars in the United States has increased exponentially in recent years. Within the oncology market, there are currently 14 approved biosimilars, with 11 launched since the start of 2019. The emergence of new oncology biosimilars provides a tool for success in value-based care, and has the potential to lower costs to patients and providers and expand access to care. Methods: Analysis of biosimilar prescribing behavior was performed using 2020 prescription data (Wolters Kluwer, n = 130,836), sales data (IQVIA), and dosage data for patients taking bevacizumab, trastuzumab, rituximab, or an FDA-approved biosimilar for these products (FDA Purple Book), between 2019-2021 (ION Solutions, n = 69,884). Drugs not directly interchangeable with the bevacizumab, trastuzumab or rituximab reference products according to NCCN guidelines were excluded. Results: Biosimilar products are currently available for bevacizumab (2 biosimilars), rituximab (3 biosimilars), and trastuzumab (5 biosimilars). We found that in 2020, 8.2% of new prescriptions for any of these three reference products were for a biosimilar. An analysis of real-world drug administration data revealed that in the 3 months following the 2019 launch of trastuzumab’s first biosimilar (trastuzumab-anns), 7.3% of initiating line 1 patients were prescribed the biosimilar over the reference product. During the same period in 2020, when a total of 5 trastuzumab biosimilars were available, 80.5% of initiating line 1 trastuzumab patients began treatment on a biosimilar, suggesting rapid uptake by providers. However, this differed by product, with the initial uptake for the first rituximab biosimilar (rituximab-pvvr), at only 2.3%. Uptake also occurred within treatment lines, with 11.1% of all patients (bevacizumab: 11.3%, trastuzumab: 14.1%, rituximab: 7.9%) switching from a reference product to a biosimilar during treatment. Uptake was particularly rapid for trastuzumab biosimilars: among patients on trastuzumab at the time of its first biosimilar launch, 18.2% switched to trastuzumab-anns in the first 90 days post-launch. Biosimilars launched at significantly lower prices than their reference products, with cost per prescription at -42.0%, -29.9% and -89.5% relative to the reference product for trastuzumab, rituximab and bevacizumab, respectively. However, biosimilar launches had little impact on reference product pricing, with 2019-2020 year-over-year (YOY) differences in price per prescription close to the YOY averages in previous years (2015-2019) for all three reference products. Conclusions: We conclude that uptake of biosimilars among oncology providers between 2019-2020 was rapid, although the extent of biosimilar prescribing varied among products. Biosimilars offered greatly reduced costs to providers, although reference product prices remained stable despite increased biosimilar competition.

Improving oncology biosimilar launches in the EU, the USA, and Japan: an updated Policy Review from the Southern Network on Adverse Reactions

The EU, the USA, and Japan account for the majority of biological pharmacotherapy use worldwide. Biosimilar regulatory approval pathways were authorised in the EU (2006), in Japan (2009), and in the USA (2015), to facilitate approval of biological drugs that are highly similar to reference products and to encourage market competition. Between 2007 and 2020, 33 biosimilars for oncology were approved by the European Medicines Agency (EMA), 16 by the US Food and Drug Administration (FDA), and ten by the Japan Pharmaceuticals and Medical Devices Agency (PMDA). Some of these approved applications were initially rejected because of manufacturing concerns (four of 36 [11%] with the EMA, seven of 16 [44%] with the FDA, none of ten for the PMDA). Median times from initial regulatory submission before approval of oncology biosimilars were 1·5 years (EMA), 1·3 years (FDA), and 0·9 years (PMDA). Pharmacists can substitute biosimilars for reference biologics in some EU countries, but not in the USA or Japan. US regulation prohibits substitution, unless the biosimilar has been approved as interchangeable, a designation not yet achieved for any biosimilar in the USA. Japan does not permit biosimilar substitution, as prescribers must include the product name on each prescription and that specific product must be given to the patient. Policy Reviews published in 2014 and 2016 in The Lancet Oncology focused on premarket and postmarket policies for oncology biosimilars before most of these drugs received regulatory approval. In this Policy Review from the Southern Network on Adverse Reactions, we identify factors preventing the effective launch of oncology biosimilars. Introduction to the market has been more challenging with therapeutic than for supportive care oncology biosimilars. Addressing region-specific competition barriers and educational needs would improve the regulatory approval process and market launches for these biologics, therefore expanding patient access to these products in the EU, the USA, and Japan.

PBI69 INSIGHTS INTO FUTURE AUTOIMMUNE PRICING DYNAMICS IN EU5 & THE US, USING LEARNINGS FROM RHEUMATOID ARTHRITIS

The rheumatoid arthritis (RA) market has historically had many ‘disruptive’ events (new products and classes, indications extensions, biosimilar launches and new formulations) influencing pricing. The objective for this project was to take learnings from these historical events and apply to an auto-immune condition to predict future price changes in EU5 and the US. An RA price evolution was conducted for EU5 and the US, highlighting key disruptive events and subsequent impact on price. A ‘matching exercise’ between those in the auto-immune space and analogous RA products allowed formation of price projections in each market. In the US, ∼5% annual list price inflation is expected, with pricing dynamics occurring at the net price level. LoE events or biosimilar introduction in the near term (the next 5-7 years) is not expected to significantly impact net price. Although net price is expected to decline with time on the market and class crowding (∼30% reductions seen with anti-TNFs). Conversely, in European markets, disruptive events are expected to change list pricing dynamics. In France especially, a cross-therapy price convergence is expected, catalysed by biosimilar introduction and LoE events. Originator list price erosions may be as high as 40% in 5 years (seen post-biosimilar launch). Dissociation from biosimilar benchmarks may be possible for new launches by targeting sub-groups with a greater unmet need (with 5-15% price premiums seen in RA), and may have a lower long-term list price erosion. In Germany, list prices are expected to remain stable over time unless a biosimilar launch reaches ∼20% market share, causing a formation of reference price group with the originator; then list price drops are expected. The auto-immune space is set to become more competitive, with products across EU5 and the US providing discounts to remain competitive

Major drug firms have active first half

Big pharma firms reported steady revenues for the first half of the year. But beneath that calm, they have been working furiously to reshape their businesses for future survival. The period was marked by divestments and acquisitions meant to strengthen their research engines. Several firms are grappling with patent losses on top-selling products. For example, revenues are flagging at AbbVie because of its reliance on the arthritis treatment Humira. Although Humira won’t see generic competition in the US until 2023, biosimilar launches in Europe caused sales of the drug to decline nearly 32% in the first 6 months of 2019, to $9.3 billion. AbbVie is counting on its recently announced acquisition of Allergan to breathe life back into its business. The $63 billion deal gives AbbVie a portfolio of specialty pharmaceuticals, including the lucrative wrinkle eraser Botox. The purchase of Allergan is among the largest in a wave of transactions

Biosimilars: A Value Proposition.

Biosimilars are biological agents that effectively replicate original reference products. The main driver of their development is the promise of bringing competition into the marketplace, and consequently contributing to the sustainability of healthcare systems. By reducing financial barriers to biological therapies, biosimilars play a part in budgetary redistribution and, hence, in increasing patients' access to treatment. They also foster innovation and deliver other non-price-driven advantages. However, the market is such that harmonization of pricing of reference biologics and biosimilars may dissuade physicians from prescribing biosimilars and often creates an unfavorable market environment for the launch of biosimilars. Such dynamics result in a high cost by denying patients the full benefits and added value inherent in biosimilar agents. A more equitable offering of established original biologics and biosimilars is needed to ensure the viability of current healthcare services.

PHP218 - HOW HIGH CAN YOU GO? - THE IMPACT OF INDICATION EXPANSION AND MARKET COMPETITION ON DRUG PRICES IN THE EU5

To examine the impact of indication extension and market competition on the prices of expensive immuno-oncology (IO) therapies and biologics used for immune-related disorders in the EU5. A targeted search was conducted in PubMed and the EMA website to identify IO drugs and biologics for immune-related disorders, approved for >1 indication. As several biologic treatments are available for immune-related diseases, only drugs with a major market share (>10%) were considered. For each drug, the launch date per indication was identified based on when the reimbursement recommendation was published. Where possible, historical list prices for the IO drugs (nivolumab, pembrolizumab, trastuzumab) and biologics (adalimumab, etanercept, infliximab) were obtained for the launch years from country-specific official journals. In the absence of official historical price sources, sales revenue and volume estimates from the IQVIATM database - IMS MIDAS Quantum, were used to determine price fluctuations Prices decline following an indication expansion across the EU5. Among IO drugs, the prices of nivolumab and pembrolizumab declined substantially following reimbursement of their second indication. This decline in price varies considerably across the EU5; ∼10%-38%. This could be attributed to the fact that both drugs were initially approved for a narrow/orphan indication and then subsequently for an indication with a larger target population. Until recently, the prices of adalimumab, etanercept and infliximab declined marginally following reimbursement approval for an additional indication. A sharp decline in prices was observed in 2017 for adalimumab, 2015 for etanercept and 2014 for Remicade, potentially associated with the launch of biosimilars. For most drugs, the decline in prices was higher in France compared to Germany and the UK Evidence shows that in general, prices decline substantially following an indication expansion. The extent of price reduction depends on various factors such as the size of the new target population and market dynamics.

PSY35 - Impact of Etanercept Biosimilar Launches on Healthcare Spending: A UK Budget Impact Model For The Treatment of Rheumatoid Arthritis And Chronic Plaque Psoriasis

PSY35 - Impact of Etanercept Biosimilar Launches on Healthcare Spending: A UK Budget Impact Model For The Treatment of Rheumatoid Arthritis And Chronic Plaque Psoriasis

A Single-use Strategy to Enable Manufacturing of Affordable Biologics

The current processing paradigm of large manufacturing facilities dedicated to single product production is no longer an effective approach for best manufacturing practices. Increasing competition for new indications and the launch of biosimilars for the monoclonal antibody market have put pressure on manufacturers to produce at lower cost. Single-use technologies and continuous upstream processes have proven to be cost-efficient options to increase biomass production but as of today the adoption has been only minimal for the purification operations, partly due to concerns related to cost and scale-up. This review summarizes how a single-use holistic process and facility strategy can overcome scale limitations and enable cost-efficient manufacturing to support the growing demand for affordable biologics. Technologies enabling high productivity, right-sized, small footprint, continuous, and automated upstream and downstream operations are evaluated in order to propose a concept for the flexible facility of the future.

D’orthoclone au dénosumab

Monoclonal antibodies are a specific medicinal category within the current therapeutic armamentarium. Their market share is growing fast as they are often the only therapeutic option at some stages of certain diseases, due to their targeted action in the body and to an acceptable tolerance. The budget impact of monoclonal antibodies is increasing, leading payers and health authorities to growing attention and pressure when they have to decide on the reimbursement, coverage and pricing of these products. The launch of biosimilars after patent expiry of some of these drugs will take time in view of the complexity of these molecules, and is not likely to significantly impact the cost of these therapies.

Fractured European market undermines biosimilar launches

Fractured European market undermines biosimilar launches