Regulations not the only barrier to biosimilars in the US say analysts

US Biosimilars market still some way away despite recent regulatory progress, analysts

A robust US biosimilars market is still some way off according to analysts who say interchangability, doctors’ safety concerns and patient demands should be considered alongside the regulatory environment by firms mulling entry.

According to data from EvaluatePharma, biopharmaceuticals – or biotech drugs – brought in revenue of $65.4bn (€58.4bn) in the US in 2012. IMS Health suggests this increased to $92bn in 2013.

The perceived wisdom is that when biosimilars join a market it forces branded biopharma firms to cut prices to preserve share, which is what happened when Dr Reddy’s launched its Rituxan copycat Reditux in India in 2007.

Similarly, in Europe, Merck & Co has predicted it will be forced to cut the price of Remicade as a result of competition from Celltrion’s Remsima and Hospira’s Inflectra.

In the US, a similar impact has been predicted. In 2008, the Congressional Budget Office (CBO) suggested biosimilars would save the Government $25bn between 2009 and 2018.

Some economists still hold this view.

Others suggest the slow progress made since the Biologics Price Competition and Innovation Act (BPCI) became law is indicative of US peculiarities that are delaying market development.


Saurabh Aggarwal from NOVEL Health Strategies told that: “In the US, the short term challenges are the State substitution laws."

When the Patient Protection and Affordable Care Act (PPAC) became law in 2010 - bringing with it the BPCI - it defined when a biosimilar can be switched for an originator – its interchangability – by the dispensing pharmacist.

The tricky bit – for biosimilars developers – is that it was left up to individual States to decide the precise requirements needed to substitute a biosimilar for a prescribed reference product.

The result is that a patchwork of subtle State to State variations now exists. Biosimilars firms need to understand and be able to navigate these to maximise sales.

Safety focus

In the longer term "The challenge will be in driving uptake, for which physicians have to truly believe in the product, in terms of safety and efficacy” according to Aggarwal.

Our discussions with physicians revealed that they have some concerns regarding safety of biosimilars. Unlike most generics which are used for primary care indications, most biologics are used for severe, complex and life threatening disease. The bar for safety is much higher for biologics.

Due to these safety concerns, the uptake curve for biosimilars is likely to relatively slower than most generics,” he said, adding “Unless, major clinical guidelines such as ACR, ASCO and NCCN endorse these products, biosimilar manufacturers will need to generate more long safety evidence to convince physicians.”

Price competition

Another issue biosimilar firms must address is the demand for value added products according to GlobalData analyst Lakshmi Dharmarajan, who suggested that US patients would be unlikely to switch from a branded product based on price alone.

She told us that “Providing other value-added features, such as multiple delivery devices, auto injector technologies and different formulations, would enable manufacturers to gain patient preference.”

Biosimilars firms also need to work with insurers to crack the US market according to Dharmarajan, who said: “Since company rebates to health plans influence market shares, developing relationships with different payers would be essential, especially in the US market.”

She also suggested that: “Biosimilar manufacturers would have to invest heavily on sales and marketing in order to build their biosimilar brand name and to establish market presence."

Related News

US FDA predicts workload hike

US FDA expects more resources to fund biosimilar reviews and plant inspections

Netherlands Medicines Evaluation Board says no ‘relevant differences’ between biosimilars, reference products

Netherlands Medicines Evaluation Board says no ‘relevant differences’ between biosimilars, reference products

NJ Assembly committee approves biosimilar substitution bill

NJ Assembly committee approves biosimilar substitution bill

Finnish Medicines Agency: No evidence of adverse events from biosimilar switches

Finnish Medicines Agency: No evidence of adverse events from biosimilar switches

Infliximab biosimilar has a 69% discount on its reference product, Remicade, in Norway. This has helped push market share to nearly 80%

Biosimilar discounts and switching will wipe-out J&J's Remicade in Norway, says regulator

Delivery devices could help firms get ahead in the increasingly competitive biologics world. Image: wimammoth/iStock

Biologic makers looking to delivery devices to gain competitive edge, Bespak

Image: Muralinath/iStock

US biosimilars in 2016: Where we're at following Zarxio's breakthrough

Repatha using the Pushtronix delivery system was approved in the US last month. Image: c/o Amgen

West: Amgen mAb approval helps validate drug delivery tech

Image: iStock/MichellePatrickPhotographyLLC

American-made biosimilars a differentiator in US market, Coherus

Recent regulatory recommendation was inevitable step in opening doors for biosimilars in the US

FDA should expect more submissions as US biosimilar doors open, says consultant

The first US challenger to Remicade will be assessed by the Arthritis Advisory Committee next month

Hospira's Remicade copycat up for FDA review as US biosimilars March on

In the post... Hospira latest to announce US biosimilar submission

US biosimilar advancement: Next up, Hospira's epoetin alfa

US FDA delays Celltrion meeting

US FDA postpones Celltrion's Remicade biosimilar review meeting

Drugmakers must show whether a biosimilar is expected to produce the same clinical result as the reference product in any given patient, according to draft FDA guidance

US FDA calls industry to help address biosimilar interchangeability

The recommendation took place during a meeting of the Oncologic Drugs Advisory Committee (ODAC) yesterday at the US FDA's headquarters in White Oak, Maryland

Biosimilars one step closer to US market after FDA gives nod to Sandoz

Apotex may join US white blood cell booster market in 2015

Apotex's Neupogen biosimilar could be battling Sandoz's copycat in the US in 2015

Zarzio (Zarxio in US) given thumbs up by FDA committee; other biosimilars may face longer meetings says expert

Biosimilar mAbs may have tougher time winning US FDA approval says expert

Related Products

See more related products