The paper examined biosimilar substitution policies across Europe, looking for commonalities among them which led to successful and sustainable biosimilar markets. The paper found that across Europe, biosimilars have:

• Increased competition
• Reduced unit cost of both originator and biosimilars compared to price levels prior to the arrival of biosimilars
• Increased volume consumption of molecules with biosimilar competition thus expanding market access and optimizing patient dosing
• Alleviated budget pressures by providing headroom to fund novel treatment solutions

While the policies by which this has been achieved vary somewhat between countries, the paper reveals that all major European markets share the following features:

• Automatic substitution for biologicals is forbidden
• All approved biologicals, i.e. originators and their biosimilars, are available on the market and are reimbursed when prescribed
• Reimbursement decisions on novel treatment solutions are independent from biosimilar use and uptake
• The time from market approval to first product sales for biosimilars is shorter than the time to first sales of novel medicines

Read the whitepaper here. 

The World Health Organization (WHO) recently released the results of a 20-country survey which identified barriers to biosimilar adoption, the Center for Biosimilars reports. Entitiled “Regulatory challenges with biosimilars: an update from 20 countries”, the survey was a follow-up to one conducted ten years prior. While most of the issues identified in the earlier survey have been resolved, the authors report, a few remain including the lack of a consistent international standard for biologic naming. “There is still no consensus among countries on the naming and labeling of biosimilars,” they observe, and the WHO does not provide specific nomenclature for biosimilars.

Some countries including Canada and those in Europe, use the brand name and international nonproprietary name (INN) that latter of which is shared between the reference biologic and all its biosimilars. Other countries, including the United States and Japan use a suffix or other identifier as part of the name.

The authors stressed that naming and labeling are important for good pharmacovigilance, which they call “essential for establishing the safety and efficacy of interchangeability of biosimilars.” There are concerns, they say, about “prescription mix‐ups, unintentional switching, and questions on traceability.” To address these concerns, the authors recommended biosimilars be clearly identifiable, using a unique brand name with the international proprietary name, and the lot number be provided.

Following years of study on the issue including findings from the first 20-country survey, in 2014 the WHO’s INN Expert Group in fact proposed a voluntary naming standard which would address these concerns.

Under the proposed system, all biologics sharing an INN be assigned a unique four-letter suffix called a “biological qualifier” or BQ, tied to the marketing authorization holder (MAH). Advantages of such a system include increased transparency, decreased likelihood of inadvertent or inappropriate substitution, improved traceability including more accurate attribution of adverse events to the correct product, and increased manufacturer accountability for their products.

While initially recieving strong support from many national regulatory authorities including the FDA, Health Canada, and Australia’s Therapeutic Goods Administration (TGA), the BQ proposal has not yet been implemented. In the absence of WHO making this system available, in 2015 the FDA adopted its own BQ-like suffix system.

In 2018, Australia adopted the European approach citing lack of WHO progress on implementation of the BQ system. Similarly, until 2019 Health Canada was in conversations with FDA about harmonizing distinct nomenclature systems regionally, but ultimately went with the brand+INN approach used in Europe, again citing lack of WHO action on distinct naming as a reason. However, both Canada and Australia have expressed their willingness to harmonize with the WHO standard were it to be made available.

Learn more about the BQ proposal here.

Read a summary of the paper’s findings here.

Read the paper here. 
 

FDA Approves 29th Biosimilar, Third for Rituximab
On December 17th, the US Food and Drug Administration (FDA) approved Rianbi (rituximab-arrx). Rianbi (rituximab-arrx) is manufactured by Amgen and the third FDA-approved biosimilar to Genentech’s Rituxan (rituximab). It is the third biosimilar FDA has approved in 2020 and the 29th approved in the past 5 years.

Read more about the successes FDA’s of the biosimilar program here.

Rianbi (rituximab-arrx) is indicated to treat adult patients with non-Hogkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis.

Rianbi (rituximab-arrx) will launch in January 2021. According to the manufacturer, its wholesale acquisition cost (WAC) will be 23.7% lower than the originator, 15.2% lower than Truximab (rituximab-abbs) and comparable to that of Ruxience (rituximab-pvvr). At launch its average sale price (ASP) will be 16.7% lower than the originator.

Learn more about the approval here. 

Read the label/packaging insert for Rianbi (rituximab-arrx) here. 

On December 9th, ASBM Advisory Board Chair Philip Schneider presented virtually to the Saudi Society for Rheumatology. The presentation was carried live to gatherings of rheumatologists in Riyadh, Saudi Arabia; Kuwait City, Kuwait; and Baghdad, Iraq.

Entitled “Lessons from European Biosimilar Markets”, the presentation was based on the whitepaper “Policy recommendations for a sustainable biosimilars market: lessons from Europe” published February 2020 in the GaBI Journal and co-authored by Reilly and Schneider.

The paper examined biosimilar substitution policies across Europe, identifying factors which led to their successful and sustainable biosimilar markets.

The analysis identified six principles the authors refer to as the “Gold Standard”: 

• Policies should be designed to incentivize and reward innovation in all types of biologicals.
• Healthcare financing must take into account societal benefits derived from biological medicines, as well as the unique characteristics of biologicals.
• Procurement practices must provide for multiple suppliers and a minimum term of 12 months.
• Physicians must have autonomy to choose the most appropriate medicine for their patient, including making decisions on switching, which must also be consented to by the patient; no automatic substitution.
• Mandatory brand-name prescribing to avoid unintended switches and a robust pharmacovigilance system to report adverse drug reactions (ADRs).
• Policies with potential to undermine sustainability, such as measures which induce biosimilar uptake or promote preferential treatment, thereby limiting physician choice, should be avoided.

The paper also identified three “Must-Haves” for a sustainable biosimilar market:

• Physicians should have the freedom to choose between off-patent originator biologicals and available biosimilars and to act in the best interest of their patients based on scientific evidence and clinical experience.
• Tenders should be designed to include multiple value-based criteria beyond price, e.g. education, services, available dose strengths, and provide a sufficient broad choice (multi-winner tenders versus single-winner tenders) to ensure continuity of supply and healthy competition.
• A level playing field between all participating manufacturers is the best way to foster competition; mandatory discounts which place artificial downward pressure on manufacturers do not engender a sustainable market environment.

Read the whitepaper here. 

On November 19th, the US Food and Drug Administration (FDA) issued new Draft Guidance entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act”
The document offers insights into how FDA will handle certain aspects of submissions and labeling for interchangeable biosimilars.

These include how an applicant may seek FDA review for licensure for an interchangeable biosimilar, and how a 351(a) BLA holder should proceed if it seeks licensure of its biological product under section 351(k) as biosimilar to or interchangeable with another biological product licensed under section 351(a) (a “reference product”). In addition, the document discusses recommendations for labeling of interchangeable biosimilars.

When finalized, FDA will move the questions and answers from the draft guidance to its companion final questions and answers guidance on biosimilar development.
Comments will be accepted on the Draft Guidance until January 19, 2021.

Read the Draft Guidance here. 
Comments may be submitted here. 

Missed last month’s ASBM Newsletter? Read it Here.

ASCO Gastrointestinal Cancers Symposium

Virtual – January 15-17, 2021

DIA Latin America Regulatory Conference

Virtual – February 22-23, 2021

World Biosimilar Congress USA 2021

Virtual – March 29-31, 2021

WHO 72nd INN Consultation

Geneva, Switzerland – April 12, 2021