Product Profile: Fulphila

Product Profile:

Fulphila (pegfilgrastim-jmdb)

Drug Category: Granulocyte colony–stimulating factor

Target Indications: Reduce the incidence of infection in patients with nonmyeloid malignancies receiving myelosuppressive anti‑cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Co-developed by Biocon and Mylan; Marketed by Mylan in the US

Summary:  Fulphila (initially designated MYL-1401H) is a biosimilar version of pegfilgrastim (reference product, Neulasta, Amgen) co-developed by Mylan/Biocon. Fulphila is marketed in the US by Mylan. A biologic license application for approval via the 351(k) biosimilar pathway was submitted to the Food and Drug Administration (FDA) in February 2017, with the FDA issuing a Complete Response Letter issued in October 2017. After a resubmission, the biologic was approved by the FDA in June 2018.

About the Manufacturer

Mylan and Biocon initiated a joint venture in 2009 for multiple biosimilar products and insulins. They co-developed the compound. Mylan GmbH will manufacture the biologic and has commercialization rights in the U.S for Fulphila, in addition to Canada, Australia and New Zealand, and the EU. Biocon has manufacturing and commercialization rights elsewhere globally. Mylan is headquartered in Pennsylvania while Biocon has their headquarters in India.

News, Commentary, and Intelligence

Competitor Products and Manufacturer Analysis

Fulphila is the first pegfilgrastim biosimilar to reach the market. The drug entered the marketplace at a 33% discount to the list price of Neulasta.

Pegfilgrastim Biosimilars Approved and in Development

Company name, Country

Product name

Brand name

Stage of development

Approved

 

 

 

Coherus

CHS-1701

Udenyca

Refiled application in May 2018. FDA approved November 2, 2018

In Development

 

 

Adello                             

TPI-120

 

Application possible in 2018

Apotex

 

Lapelga

Submitted December 2014. No FDA action reported (complete response letter issued?)

Sandoz

LA-EP2006

 

Submitted December 2015; Complete response letter issued, June/July 2016; withdrew EMA application January 2017; new application possible 2019

Coherus Gets FDA Approval for Its Pegfilgrastim Biosimilar

(November 2, 2018) With the Food and Drug Administration (FDA) approval today of Coherus Bioscience’s Udenyca™ (pegfilgrastim-cbqv), the second pegfilgrastim to compete with Amgen’s Neulasta®, much attention will be now focused on the company’s November 8 earning call.

Tidal Wave of Pegfilgrastim Biosimilars About to Hit Europe

(September 27, 2018) The European Medicines Agency (EMA) has had an extremely busy week in the pegfilgrastim biosimilars arena. In addition to granting marketing authorization to Coherus Biosciences for its pegfilgrastim biosimilar, it has also approved the marketing of Pelgraz®, a pegfilgrastim produced by Accord Healthcare. In addition, the EMA’s Committee for Medicinal Products for Human Use has also recommended approval for three pegfilgrastim biosimilars—from Sandoz, Cinfa, and Mylan.

Mylan’s Fulphila Pegfilgrastim Biosimilar Launches at Big Discount

(July 30, 2018) The first pegfilgrastim biosimilar lgrastim (Fulphila™) in the US has begun marketing, and Mylan/Biocon are offering a 33% discount to the wholesale acquisition cost (WAC) of the originator product Neulasta®. This is a watershed moment for the pegfilgrastim category and could signal the beginning of large savings opportunities for payers and patients.

Mylan Rethinking Its US Business Strategy?

(August 9, 2018) In reporting lower earnings on its second-quarter revenues, Mylan may have surprised industry observers by offering the possibility of some changes in strategic direction.

FDA Advisory Committees on Biosimilar Applications: Mylan’s Latest Muddies the Waters Further

(June 18, 2018) When the Food and Drug Administration (FDA) approved the first biosimilar pegfilgrastim (Mylan’s Fulphila™), it broke precedent in more ways than one. Not only was this the first biosimilar member of the pegfilgrastim class to be approved, but its approval did not require an FDA Advisory Committee recommendation.

Mylan and Biocon Land First Pegfilgrastim Biosimilar Approval

(June 3, 2018) The race to bring a pegfilgrastim biosimilar to market officially started on December 17, 2014. The checkered flag fluttered 3½ years later on June 4, 2018, with the Mylan/Biocon team winning on a slow track.

What Is the Biosimilar Pegfilgrastim Market Opportunity?

(May 25, 2018) At a current 62% marketshare for Neulasta Onpro, the initial total slice of the pie available for biosimilars may only be $1.5 billion (not considering WAC discounts).

The FDA Rejects Mylan/Biocon’s Pegfilgrastim; Market Still Awaits a Biosimilar for Neulasta

(October 11, 2017) In the latest blow to those seeking an alternative to Amgen’s Neulasta®, the Food and Drug Administration (FDA) sent a complete response letter to Biocon, citing manufacturing plant deficiencies, in its rejection of their biosimilar pegfilgrastim application.).

Avoiding Neutropenic Infection: A Nurse's Perspective

Neutropenic Fever

Clinical Trials of Fulphila

Clinical Trial Results

Pivotal Trial for Approval: A study comparing MYL-1401H to Neulasta in stage II/III breast cancer patients receiving neoadjuvant or adjuvant chemotherapy.

A phase III multicenter, randomized, double-blind parallel-group with 194 patients that were chemotherapy radiotherapy naïve-patients with newly diagnosed stage II/III breast cancer. The patients received docetaxel, doxorubicin, and cyclophosphamide therapy every 3 weeks for 6 cycles of therapy. Patients were randomized 2:1 to receive 6 mg/0.6 mL of either MYL-1401H or the reference product EU-Neulasta on day 2 of each chemotherapy cycle. Duration of severe neutropenia (e.g. days with absolute neutrophil count <0.5 X 109/L) in cycle 1 was the primacy efficacy endpoint.

Equivalency was defined using a two-sided 95% confidence interval of the least squares means difference between the duration of severe neutropenia being between a defined region of -1, +1 day. The sample size was chosen to provide 90% power that the therapies were comparable.

Results:

MYL-1401H

EU-Neulasta

Treatment Difference

Mean Days of Severe Neutropenia (DSN)

1.2 ±0.93

1.2 ± 1.10

95% CI of least squares means difference [-0.285 day, 0.298 day]

The results showed that the DSN fell between the [-1 day, +1 day] range thus making the two products equivalent.

Grade 3-4 neutropenia, time to absolute neutrophil count (ANC) nadir, and duration of post-nadir recovery were also endpoints that were comparable. Bone pain as well as the overall safety profile of the two products were similar.

Phase I Trial: Pharmacokinetic/pharmacodynamic study comparing MYL-1401H, EU-sourced Neulasta and US-licensed Neulasta 

 

Important Links and Resources

 

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