Insights+ Key Biosimilars Events of February 2020
- Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
- Biosimilars are expected to be a cost-effective alternative to high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients
- The Korean firm, Celltrion's Remsima also showed some updates in fields of approval and results, as the product received KFDA's approval for RA and showed positive results in a trial for Active Crohn's Disease and Ulcerative Colitis
1. The US FDA and FTC Signed an Agreement to Support the Development of Biosimilars
Date: Feb 03, 2020
Product: Biosimilars
- The partnership addressed the false and misleading promotion of biosimilars within their respective authorities and prevent anti-competitive behavior. Additionally, the agencies will collaborate with participants from industry, academia and government agencies for discussing issues related to competition in the biologics market
- The agencies will collaboratively exchange the information for suitable practices in preventing the activities that the biosimilar is needed for testing. Also, the FTC will review the patent settlements for preventing antitrust violations
- The FDA's BAP outlined four strategies for accelerating the biosimilar competition, including supporting market competition and providing direction to industry for the development of promotional materials for medical products. The FDA and FTC will uphold a public workshop FDA/FTC Workshop on a Competitive Marketplace for Biosimilars on Mar 9, 2020, at FDA's White Oak Campus in Silver Spring, Maryland
Date: Feb 03, 2020
Product: Ruxience (biosimilar, rituximab)
- The EMA's CHMP adopted a positive opinion, recommending MAA for Ruxience, a biosimilar referencing MabThera
- The regulatory submission was based on REFLECTIONS B3281006 study assessing the efficacy, safety, immunogenicity, PK/PD of Ruxience demonstrating bio-similarity to the reference product in patients with CD20+, low tumor burden FL
- Ruxience is a mAb indicated for the treatment of NHL, CLL, RA, GPA, MPA, PV and has received the US FDA's approval in 2019 with its anticipated EC's approval in H1'20. If approved, RUXIENCE will be Pfizer's fifth oncology biosimilar to receive regulatory approval in EU
Date: Feb 03, 2020
Product: Amgevita (biosimilar, adalimumab)
- Amgen reported the launch and commercialization of Amgevita, a biosimilar of adalimumab, available in Brazil
- The ANVISA's approval was based on the clinical study demonstrating bio-similarity with the reference biological product, via vitro analyzes, PK & clinical information in patients with moderate to severe psoriasis and RA
- Amgevita is a fully human IgG1 mAb targeting TNFa, a cytokine which mediates the inflammatory response and has received ANVISA's approval for RA, PsO, CD, UC, axSpA, HS in Apr'2019
Date: Feb 04, 2020
Product: BAT1706 (biosimilar, bevacizumab)
- The P-III study involved assessing of BAT1706 vs EU Avastin (bevacizumab) + chemotherapy in patients with non-squamous NSCLC, evaluating its safety, efficacy, PK & immunogenicity
- The trial resulted in meeting its 1EPs and demonstrated the equivalence in ORR for 1L patients with advanced non-squamous NSCLC
- BAT1706 is mAb & second biosimilar in Bio-Thera's portfolio works as a vascular endothelial growth factor (VEGF) protein. Avastin is a mAb targeted to treat patients with metastatic colorectal cancer, non-squamous NSCLC, recurrent glioblastoma, metastatic RCC, persistent, recurrent, or metastatic CC, and epithelial ovarian, fallopian tube, or primary peritoneal cancer
5. The US FDA Released Draft Guidelines for Proposed Biosimilar or Proposed Interchangeable Biosimilars
Date: Feb 05, 2020
Product: Biosimilars
- The submission of the application and labeling for a proposed biosimilar or a proposed interchangeable biosimilar for fewer than all the reference product's licensed condition of use
- The submission of supplement to an application for a biosimilar or proposed interchangeable product was licensed for fewer than all the reference products
- Timing for the submission of a 351(k) BLA or supplement to a licensed 351(k) BLA for obtaining licensure for a biosimilar or interchangeable for an indication post the expiration of any relevant exclusivity or patents
6. Merck & Co. to Spin-Off its Non-Core Business into a New Company to Focus on its Core Therapy Areas
Date: Feb 05, 2020
Product: Biosimilars, Renflexis (infliximab-abda), Brenzys (etanercept), Ontruzant (trastuzumab-dttb)
- Merck spin-off its women's health trusted legacy brands and biosimilars businesses into a new company to intending to retain its focus in its core therapy areas including oncology, vaccines, hospital & animal health
- NewCo to focus on women health's product, Nexplanon (etonogestrel implant) franchise and fueled by its leading contraceptive and fertility businesses and is expected to work on biosimilar therapies including Renflexis (infliximab-abda) and Brenzys (etanercept) in immunology and Ontruzant (trastuzumab-dttb) in oncology
- Additionally, NewCo to focus on trusted brands consisting of Zetia (ezetimibe) & Vytorin (ezetimibe/simvastatin). The transaction enables Merck to achieve in excess $1.5B in operating efficiencies by 2024 with its anticipated completion in H1'21
Date: Feb 14, 2020
Product: Remsima SC (biosimilar, infliximab)
- The clinical study involved assessing the PK, efficacy, and safety of CT-P13 SC vs CT-P13 IV in 131 patients with active CD & UC for 1yr. Following loading doses of IV 5mg/kg @0 & 2wks., patients were randomized @6wks. to receive either SC 120/240 mg q2w or continued IV 5 mg/kg q8w, @30wks. IV arm switched to SC arm based on body weight
- The clinical study demonstrated that Remsima SC is comparable to its IV formulation @1yr., improvement in clinical activity, rate of clinical response and remission are maintained, improvement in the rate of clinical healing
- Remsima SC (CT-P13 SC) is the first & only SC infliximab to be available in EU for IBD in mid-2020 and has received EMA's MAA for RA in H2'19
8. The US FDA Upgraded the Purple Book to Assist the Transparency in Biosimilars
Date: Feb 24, 2020
Product: Biosimilars
- The US FDA is upgrading the Purple Book by changing it from the current list format to a searchable online database. The FDA has released the first phase that contains information on FDA-licensed biosimilar and interchangeable products along with their reference products
- The further release of phases will expand the number of FDA-licensed biological products included in the Purple Book online database until the final release, which will include information about all FDA-licensed biological products
- The expansion & digitization of the Purple Book will make information on FDA-licensed biological products more accessible & transparent for patients, industry users and other stakeholders
9. Insud's mAbxience Inaugurated New Biosimilar Plant Facility in Argentina
Date: Feb 24, 2020
Product: Biosimilars
- The development project involved an investment of $40M and doubled its production capacity and will export biosimilar in Central America, South America, Africa, Asia, and the Middle East
- The plant currently has 162 employees with 50 new jobs, and it is expected to generate another 50 positions over the coming years work according to GMP
- The company owns now three biosimilar plants two in Argentina and one in Spain (León)
10. Celltrion's Remsima SC (biosimilar, infliximab) Received KFDA's Approval for Rheumatoid Arthritis
Date: Feb 27, 2020
Product: Remsima (biosimilar, infliximab)
- The KFDA has approved Celltrion's Remsima SC for RA while the company is planning to seek approval for IBD within the year through the change permit procedure and is expected to be available to the Korean patients following the completion of the permit for the addition of IBD indications
- Additionally, Celltrion has filed an application for a Remsima SC in Canada to enter the NA and plans to supply it throughout Canada via Celltrion's direct sales network. The company is expecting to launch the therapy in the US in 2020 and currently being evaluated in P-III study
- Remsima SC is the world's first SC biosimilar referencing Janssen's Remicade (infliximab) and has received EMA's approval in Nov'2019
11. Baysient Released iDose Software Technology Platform 1.0 to Reduce the Biosimilar Cost in Market
Date: Feb 28, 2020
Product: Biosimilars
- The 12-month clinical validation study (NCT02453776) data demonstrated the reduction 'switching' from lower-cost infliximab to more expensive biologics by 66%. Also, similar studies are ongoing in 9 countries on 3 continents
- The results were already presented at ECCO, Copenhagen, Mar 2019 and DDW, San Diego, May 2019 and the Baysient pipeline includes CDS for 25 FDA approved anti-inflammatory biologics. The HCPs using iDose software's CDS reduced the cost of $726,000 per 100 patients
- The iDose algorithm is a cloud base software as a service (SaaS) and is HIPAA-compliant and compatible with EMRs offered in the US and Canada, combines the PK data with Bayesian learning (non-AI machine learning) and forecasting, also enables the physicians to understand how to keep the amount of drug in patient's body from falling below the physician-selected target
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