BioFactura’s Biosimilar Ustekinumab, Demonstrates Pharmacokinetic (PK) Bioequivalence to Stelara® in Phase 1 Study

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BioFactura’s Biosimilar Ustekinumab, Demonstrates Pharmacokinetic (PK) Bioequivalence to Stelara® in Phase 1 Study
BioFactura, Inc.
October 13, 2022, 13:03 GMT
• Phase 1 clinical study demonstrated PK bioequivalence and comparable safety and immunogenicity profiles between BFI-751 and reference Stelara®.
meeting the primary endpoint of clinical bioequivalence in this trial, along with our bioanalytical comparative data, puts BFI-751 on the way to regulatory approval and commercial launch.”— Jeffrey N. Hausfeld MD, MBAFREDERICK, MARYLAND, UNITED STATES, October 13, 2022 / — BioFactura Inc. has announced today the completion of the pivotal pharmacokinetic comparability clinical trial for its Ustekinumab Biosimilar (BFI-751). The clinical trial was conducted in two sites in Australia and one site in New Zealand. BioFactura developed BFI-751 using its proprietary NS0 host cell line-based StableFastTM Biomanufacturing Platform.
Ustekinumab is a targeted monoclonal antibody directed against the common p40 subunit of the naturally occurring proteins interleukin (IL)-12 and IL-23, which regulate the immune system. The reference product, Stelara ®, has been approved for the treatment of plaque psoriasis, active psoriatic arthritis, Crohn’s disease, and ulcerative colitis and is projected to have global market sales at $10B in 2023 prior to patent expiry.
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Kashiv Biosciences Achieves Second U.S. Biosimilar Approval with FYLNETRA® (pegfilgrastim-pbbk)

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Kashiv Biosciences, LLC (“Kashiv” or the “Company”) is pleased to announce that the U.S. Food and Drug Administration (“FDA”) has approved its Biologics License Application (“BLA”) for pegfilgrastim-pbbk, a biosimilar referencing Neulasta®. The product will be marketed under the proprietary name FYLNETRA®.

Biosimilars Market is Fertile Ground for Impact Investors

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An impact investor can be an individual or investment fund that has co-equal primary goals: to make money and foment positive social change that can last. In some ways, impact investors are “social VCs”—they fund projects and companies that can create positive, measurable impact for the greater good of humanity. Unlike traditional VC investment strategies that tend to take a high risk, high reward approach, impact investing generally focuses on lower risk, more modest or conservative financial investments that yield the most possible good for people and communities.

Despite Strong 2021 Performance Headwinds Remain for Biosimilars Uptake

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Biosimilars, also known as follow-on biologics, continued to capture greater market share and foment stronger competition with reference or brand name drugs in 2021. Increasing the number of biosimilars in the market and amplifying uptake by payers, family medical practices and pharmacies could be a gamechanger for patients and a healthcare system trying to reduce the cost of life-changing medicines.

Doogie and the Rock Star: BioFactura’s Remarkable Journey

Headshots of Darryl Sampey and Jeffrey Hausfeld
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BioFactura, a leading developer and manufacturer of biosimilars and biodefense products, is one of the crown jewels of Frederick, Maryland’s growing biotech hub. The company is thriving and has secured strong funding from both private and government sources that see the potential of the company’s StableFast™ biosimilars platform. In May 2021, BioFactura reached an important milestone, announcing that it had moved its first biosimilar product into the clinic.

The Benefits of Taking Your Career to a Growth Stage Biotech

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Over the next few years, thousands of new positions in the biopharma and life sciences industry are expected to open up across the BioHealth Capital Region and the greater Philadelphia area known as Cellicon Valley.

Whether you are fresh out of the university or a seasoned veteran, many job seekers question whether or not they should aim for large biopharmaceutical companies, such as AstraZeneca, Pfizer or GlaxoSmithKline, or look at nimble, growth-stage companies, such as American Gene Technologies, Vita Therapeutics, or BioFactura, Inc., which is currently scaling their cGMP and Quality operations.

BioFactura is on Course to Become a Global Leader in Biosimilar Development

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Since the approval of the first biosimilar drug in the United States six years ago, the market has rapidly expanded and is expected to grow to approximately $23 billion in the U.S. by 2027. And Maryland’s BioFactura anticipates it will be one of the companies at the forefront of this revolution of new medications.

BioFactura Announces MTA with Rani Therapeutics

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BioFactura Inc. (“BioFactura”), a leading developer of high-value biosimilar and biodefense drugs using its patented StableFast™ platform, announces an agreement with Rani Therapeutics (“Rani”) to assess its Ustekinumab Biosimilar (BFI-751) in combination with Rani’s RaniPill™ platform.

BioFactura CEO Dr. Darryl Sampey Shares his Entrepreneurial Journey at Frederick’s StartupGrind Event

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BioFactura CEO Dr. Darryl Sampey Shares his Entrepreneurial Journey at Frederick’s StartupGrind Event February 26, 2019 Dr. Darryl Sampey has been through the grind as CEO of Frederick’s BioFactura, a [….]