Abrilada

Product Profile:

Adalimumab-afzb (Abrilada)

Drug Category: anti-TNF inhibitor/autoimmune

Target Indications: Treatment of ankylosing spondylitis, Crohn’s disease in adults, plaque psoriasis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis

Will be manufactured and marketed by Pfizer

Biosimilar Drug Profile: Abrilada is an FDA-approved biosimilar version of adalimumab (reference product, Humira®, AbbVie).

Originally known as PF-06410293, Pfizer submitted a biologic license application for approval via the 351(k) biosimilar pathway in the fourth quarter of 2018 (the application date was not publicly announced). The Food and Drug Administration (FDA) approved the biosimilar on November 18, 2019. This agent is not yet approved for use in the European Union.

Though approved, it is not yet marketed in the US  Like several other manufacturers of approved biosimilar versions of adalimumab, Pfizer has signed a licensing agreement with AbbVie; under the agreement, Samsung would be able to launch the drug in November 2023.

About the Manufacturer

Pfizer entered the biosimilar market through two avenues: (1) its acquisition of Hospira and (2) its own internal pipeline development. Pfizer was established in 1849, and it is headquartered in New York City. It has a considerable portfolio of biosimilar products approved by the FDA and in various stages of filing. In addition to Abrilada, its approved biosimilars include Inflectra, the first biosimilar version of Remicade; Ixifi, another version of Remicade that will be sold overseas only; Trazimera, a biosimilar trastuzumab; Retacrit, a biosimilar epoetin that was approved in May 2018; Ruxience, a biosimilar rituximab that was approved in July 2018; Nevistym, a biosimilar version of filgrastim that is also marketed; and Zirabev, a biosimilar to Avastin approved in June 2019 and presently marketed. Pfizer’s biosimilar pipeline consists of a biosimilar pegfilgrastim in phase 1 development.

News, Commentary, and Intelligence

Competitor Products and Manufacturer Analysis

Abrilada was the fifth adalimumab biosimilar to be approved by the FDA. It, like its competitors, is not yet available on the US market because of licensing agreements signed with the manufacturer of the reference product, AbbVie.

ADALIMUMAB BIOSIMILARS APPROVED BY THE FDA

Manufacturer

Brand Name & Designation

Filing Date

Approval Date/Marketing Status

Amgen

Amjetiva (adalimumab-atto)

November 25, 2015

Approved September 23, 2016, all indications; not yet marketed; Signed licensing agreement with AbbVie to launch January 2023

Boehringer Ingelheim

Cyltezo (adalimumab-adbm) 

January 18, 2017

Approved August 29, 2017; Signed licensing agreement with AbbVie to launch July 2023

Sandoz

Hyrimoz (adalimumab-adaz)

January 16, 2018

Approved October 31, 2018; Signed licensing agreement with AbbVie to launch Sept 2023

Samsung Bioepis

Hadlima (adalimumab-bwwd)

September 27, 2018

Approved July 22, 2019; Signed licensing agreement with AbbVie to launch June 2023

Pfizer

Abrilada (adalimumab-afzb)

Q4 2018

Approved November 18, 2019; Signed licensing agreement with AbbVie to launch November 2023

Mylan/Fujifilm Kyowa Kirin Biologics

Hulio (adalimumab-fkjp

Q4 2019

Approved July 6, 2020; Signed licensing agreement with AbbVie to launch August 2023

ADALIMUMAB BIOSIMILARS IN DEVELOPMENT
Company Name Product Name Stage of Development
Coherus Biosciences CHS-1420 Submitted 351(k) application December 2020; FDA decision expected Q4 2019
Fresenius Kabi MSB11022 Completed phase 3 study; FDA filing may occur in 2021
Celltrion CT-P17 Phase 3 trials completed; FDA filing may occur in 2021

Adalimumab Biosimilar Approval for Mylan and Fujifilm Kyowa Kirin

(July 6, 2020) On July 6, the Food and Drug Administration approved partners Mylan/Fujifilm Kyowa Kirin Biologics’ biosimilar version of adalimumab for use in patients with autoimmune diseases.

Pfizer Reaches Milestone: FDA Approves 25th Biosimilar in US

(November 20, 2019) Pfizer announced November 18th that the biosimilar licensing application (BLA) for its adalimumab biosimilar was approved by the Food and Drug Administration (FDA).

Momenta Drops Out of Biosimilar Adalimumab Competition

(August 5, 2019) “Today, Momenta announced the Company will cease active development of M923 at this time, due to changes in the market opportunity associated with Humira patent litigation settlements,” according to a company press release.

The Biosimilar Mabs Have It: FDA Approves Samsung Bioepis' Adalimumab

(July 24, 2019) In a busy beginning of the week, the US Food and Drug Administration approved new biosimilars for Humira and RituxanSamsung Bioepis gained approval for Hadlima™ (adalimumab-bwwd), and Pfizer scored with Ruxience™ (rituximab-pvvr).

Samsung Bioepis Signals a Settlement With Genentech on Herceptin Biosimilar

(July 12,  2019) Samsung Bioepis and Genentech filed a motion in District Court to drop all pending patent litigation regarding Ontruzant, an approved Herceptin biosimilar.

Boehringer Ingelheim Gives up the Fight, Signs AbbVie Agreement on Adalimumab

(May 15, 2019) This agreement allows Boehringer Ingelheim to enter the marketplace July 1, 2023, getting a slight jump on some other licensees, but it effectively ends the protracted patent litigation that Boehringer hoped to win.

Update: Who Has Signed Abbvie Licensing Agreements for Adalimumab Biosimilars?

(January 28, 2019) At least 8 biosimilar manufacturers have signed licensing agreements with Abbvie, which allow immediate European launches for approved adalimumab biosimilars and sequentially timed US launches in 2023. This database displays the manufacturer, product name, and date of anticipated launch. Note: not all of these biosimilar adalimumab are approved in the US.

More Adalimumab News: Abbvie Signs a Licensing Deal With Coherus, Coherus Sues Amgen for Patent Infringement

(January 28, 2019) Coherus becomes the eighth biosimilar maker to sign a licensing agreement with Abbvie, and it also becomes the first biosimilar maker to sue another (Amgen) for patent infringement.

Pfizer Pulls One Biosimilar Adalimumab Application From the EMA

(December 17, 2018) Earlier this month, Pfizer notified the European Medicines Agency (EMA) that it was withdrawing one of its two applications for approval of its biosimilar adalimumab.

Boehringer Ingelheim Decides to Market Cyltezo® in the US Only

(November 28, 2018)  Boehringer has now announced its intention to discontinue all efforts to market and develop any biosimilars outside of the US market.

Pfizer Signs Licensing Deal With Abbvie on Adalimumab Biosimilar Candidate

(November 27, 2018)  According to the announcement, Pfizer will market this agent (PF-06410293), if approved by the Food and Drug Administration, in November 2023.

A Third Biosimilar Adalimumab Approval in the US

(November 1, 2018)  The Food and Drug Administration (FDA) announced yesterday the approval of adalimumab-adaz from Sandoz. The new agent, dubbed Hyrimoz™, will not be launched in the US until 2023.

Word From the Adalimumab Front: A Conversation With Molly Burich, MS, Boehringer Ingelheim: Part 2

(October 24, 2018) In part two and the conclusion of this interview, Molly Burich, MS, Director, Public Policy: Biosimilars and Pipeline, speaks to Boehringer Ingelheim’s progress in Cytelzo interchangeability studies, its plans for the product in Europe in the face of several adalimumab biosimilars launches in the EU, and also the complexity inherent in CMS’s plans to move biologic agents from part B to part D coverage.

Word From the Adalimumab Front: A Conversation With Molly Burich, MS, Boehringer Ingelheim: Part 1

(October 23, 2018)  In the first portion of a two-part interview with Molly Burich, MS, Director, Public Policy: Biosimilars and Pipeline, Boehringer Ingelheim, we cover the challenges of driving biosimilar uptake, as well as the unique situation that has focused this manufacturer’s attention on biosimilars and interchangeability.

Part B to Part D and Other Questions: How CMS’s Plans Could Affect Biosimilars

(August 10, 2018)  Some of these tactics are a bit late to the party, as commercial insurers and health plans have been employing them for years. To the extent that an injectable treatment can be managed through the pharmacy benefit rather than the medical benefit, the drug can be easily subjected to prior authorization, step therapy, quantity limits, and other tools routinely used.

Up to 5 Biosimilar Horses in the Race for Adalimumab in Europe: Heading for the Starting Gate

(August 3, 2018) A long-sought dream in the United States will be a welcome reality in Europe this October: a stampede for Abbvie’s marketshare with adalimumab biosimilars and the savings that go with it.

An FDA Filing for Momenta’s Adalimumab Biosimilar Coming Soon?

(June 22, 2018) In its recent investor conference, the company disclosed that it is ready to send M923, its adalimumab biosimilar, to the agency for approval.

With the Samsung Bioepis Deal, Abbvie Tightening Its Grip on the US Adalimumab Market

(April 6, 2018) Samsung Bioepis and Biogen has reached a deal with Abbvie that would enable it to market its biosimilar adalimumab (should it be granted approval) in June 2023.

What Will Cost Savings on 2023 Adalimumab Biosimilars Really Be Worth?

(February 5, 2018) AbbVie executives are sticking to their pledge to restrict annual price increases on Humira® below 10%, but even payer price protections won’t mitigate the increasing expenditures before adalimumab biosimilars hit the market.

Sandoz Files 351(k) Application for Adalimumab Biosimilar

(January 16, 2019) Sandoz announced that it has thrown its hat in the ring for another Humira biosimilar.

Are We Now Thinking “Authorized Biosimilars”?

(October 3, 2017) Authorized generics have been around for a couple of decades. They can be a challenge to payers, health systems, and patients who are seeking the price-reduction benefits borne out of normal competition. The Amgen-Abbvie agreement for the former’s adalimumab biosimilar is right out of this playbook.

FDA Approves New Humira Biosimilar, Bypasses Advisory Board Route

(August 29, 2017) Boehringer Ingelheim Pharmaceuticals, Inc. announced August 29 that it had received approval from the Food and Drug Administration (FDA) for its first biosimilar.

Boehringer May Seek Interchangeable Designation for Adalimumab Biosimilar

(July 28, 2017)  One biosimilar developer announced on July 27 that it is embarking on a study specifically to prove interchangeability of its biosimilar version of adalimumab.

Impressions on the Adalimumab Biosimilar Arthritis Advisory Committee Meeting

(July 12, 2017) FDA Advisory Committee members considered the data package provided by Amgen to be comprehensive, but the 26-0 vote was not without some interesting points and drama.

The Benefits of Biosimilars

The Promise of Biosimilars

Clinical Trials of Abrilada

Phase 3 Trials

Pfizer centered its clinical trial program around multiple phase 1 trials and a phase 3 investigation (the REFLECTIONS program). We summarize the phase 3 trial below.

A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira®) in the treatment of active rheumatoid arthritis.

This multinational, double-blind, randomized trial evaluated not only the clinical efficacy and safety of Pfizer’s biosimilar adalimumab drug candidate (PF-06410293) but the immunogenicity, pharmacokinetics, and pharmacodynamics of the agent compared with the EU-sourced reference product (Humira®). The study comprised 597 patients with active rheumatoid arthritis (RA) who had not taken biologics previously.

Patients (mean age, 52.5 yr; 79% female) continued their methotrexate treatment while in the 78-week trial. They had had RA for an average of 6.8 years. The primary endpoint was American College of Rheumatology 20% improvement (ACR20) at week 12. Secondary efficacy endpoints were measured at week 26 and included the percentages attaining ACR20/50/70, a European League Against Rheumatism (EULAR) “good” response, DAS28 score improvement, and ACR/EULAR remission, among others.

The Table reports the principal efficacy results in the intent-to-treat population, none of which were determined to be significantly different.

Variable

Abrilada (n = 297)

EU-Humira (n = 300)

ACR20 at week 12

68.7%

72.7%

ACR 20/50/70 at week 26*

82%/59%/30%

78%/53%/30%

Good EULAR response

54.5%

49.0%

ACR/EULAR remission

12.8%

14.7%

DAS28 score improvement

–2.7

–2.8

*Estimated from charts (no data points published).

Safety results were also very comparable. After 26 weeks, injection-site reactions occurred in 1.7% of those receiving the biosimilar and 2.0% of those being administered the reference agent. Similar findings were also registered for pneumonia (0.7% vs. 2.0%, respectively) and opportunistic infections (2.4% vs. 1.7%, respectively). Antidrug antibodies were detected in 44.4% of those in the biosimilar group and 50.5% in the originator drug group.

The investigators concluded that “the study results demonstrate that efficacy, safety, and immunogenicity of PF-06410293 and adalimumab-EU were similar during the first 26 weeks of treatment in patients with active RA on background [methotrexate therapy].”

Phase 1 Studies

A study of PF-06410293 following subcutaneous administration using a prefilled syringe or a prefilled pen In healthy adult subjects.

Study of PF-06410293 and adalimumab in healthy subjects.

A study of PF-06410293 (adalimumab-Pfizer) and adalimumab (Humira) in healthy subjects.

Important Links and Resources

Information About Biosimilars

Patient Assistance Information
(This product is not yet available for prescription)

US Biosimilar Filings Status

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