The last 6 months of 2020 inspired many headlines that interest readers at the Biosimilars Center®. For a summary of the most popular stories and related issues, read on.
July
There was a popular interview from the Center for Biosimilars® in July 2020 with Byoungseo Choi, head of marketing for Celltrion Healthcare, a rising force in the world of bio-development. He considered the company’s infliximab bios (Inflectra, Remsima) and its value in the treatment of coronavirus disease 2019 (COVID-19). He also spoke about Celltrion’s ambitious plans to launch multiple biosimilars over the next decade.
In 2020, visitors to the Center for Biosimilars® also paid close attention to stories about other bios with Cadila Pharmaceuticals of Ahmedabad, India. One such launch in July 2020 was a rituximab-like biosux (Ritucad) for the Indian market. The second Cadila launch of the same month included another Bevaro bios bevacizumab, for the treatment of ovarian cancer, glioblastoma multiforme, colorectal cancer, breast cancer, lung cancer, cervical cancer, and kidney cancer.
Although Alzumab (itolizumab) is not a bioavailability, the other bios developer Biocon Biologics drew attention in 2020 when it announced the approval of this monoclonal anti-CD6 IgG1 antibody for COVID-related disease- 19 by the General Drug Regulator of India. The drug has been indicated for emergency treatment of upper respiratory distress syndrome (ARDS) in patients with COVID-19. Biocon said the drug had value in treating cytokine release syndrome, which is common among patients with moderate-to-severe ARDS. The drug is commonly used to treat chronic plaque psoriasis.
August
As pharmaceutical companies began sharing promising news in developing COVID-19-related therapies, Anthony S. Fauci, MD, director of the National Institute of Allergy and Diseases, said at a town hall meeting. that early treatments such as monoclonal antibodies (mAbs) and direct-acting antivirals (DAAs) had contributed to impressive test results. At the time, mAb infliximab (Remsima) was being evaluated in a CATALYST study of COVID-19-related inflammation.
In addition to DAAs, which target specific virus proteins and disrupt viral replication and infectivity, there were convalescent plasma and hyperimmune globulin therapies, which involve the use of full-blood antibody from patients who has surpassed COVID-19, also candidates for potential use in pandemic conflict, Fauci said.
In the month of August 2020 Cadila launched another bios on the market in India, this time a bios-like teriparatide (NuPTH), which is indicated for the treatment of osteoporosis and increased risk for bone fractures. The drug could be an important tool in the providers ’armamentarium, Cadila said, noting that India is“ the osteoporosis capital of the world. ”The story attracted widespread attention.
September
By this time in the pandemic, many other bios developers had joined the fight to find cures for COVID-19. In some cases, biosimilars under the microscope were candidates for effective control of the disease; in others, initial biology became a focus, offering a career potential for biosimilars if the innovative results were successful. In the latter group Roche contains bevacizumab (Avastin), which was intended to offer value in the treatment of pulmonary edema associated with pulmonary edema and ARDS. Pulmonary edema involves fluid buildup in the lungs, a condition that can be suppressed by bevacizumab. The Center for Biosimilars® conducted an overview of these efforts to address the COVID-19 problem.
Related to this, mAb CT-P59 at Celltrion Healthcare showed positive results in a CATALYST level 1 test for the management of COVID-19-associated inflammation. Also, a statement published in Rheumatology Lancet they called for prioritizing the development of anti-tumor necrosis factor (TNF) therapies for the treatment of COVID-19, saying that these agents, which include biosimilars, have been neglected. “The potential of anti-TNF therapy as a treatment for COVID-19 is supported by both credible biological and observational clinical data,” the authors wrote. “Very few conventional therapies under study are this level of supporting evidence.”
Over the month of September, a published paper raised growing concerns among UK regulators about the relatively weak evidence provided by comparable biosecurity efficacy tests. Researchers have long argued that pharmacokinetic and pharmacodynamic studies can produce more accurate comparative data to show similarity to reference results and that efficacy tests do not have a strong scientific basis. human beings to perform this task. With Brexit, the UK leaving the European Union, the country is taking control for the licensing of medicines, and the UK Medicines and Healthcare products Regulatory Agency has issued guidelines saying no need for general efficacy / safety comparative testing.
October
A well-read story in October 2020 related to Amgen’s report on market share and price discounts achieved by biosimilars. Biosimilars introduce discounts on the market and capture a quote from original products, but also encourage startup companies to lower their prices for information products to maintain market share. The Amgen report showed that both dynamics have been at play in recent years. Biosimilars, Amgen said, have been gaining traction, although it depends on the type of biosimilars and the length of time they have been available in the market.
Similarly, a report from the IQVIA Institute for Human Data Science stated that concerns about the adoption of a few bios in the United States appear to be escalating. “Some common assumptions about patient and provider acceptance and comfort with biosimilars appear to be more conservative than data shows,” the report’s authors said. They estimated that drugs would make up 51% of the cost of biology versus bivalve competition over the next 10 years.
November
The renewed concerns about the value of clinical efficacy comparative trials prompted the Advisory Board of the Sarfaraz K. Niazi Biosimilars® Center, PhD, to write a column on reasons why these trials do not add much weight to evidence for other bios approval. “The relative efficacy test of redundant biosimilars is at best,” he wrote in this widely read column.
The provinces of Canada have made great strides in establishing biodiverse practice through forced change. In a November 2020 story about Alberta’s efforts in this regard, high traffic came from readers of the Center for Biosimilars®. After starting their program in 2019, Alberta saw 16% of patients switched to biosimilars from using 7 reference products, according to a presentation at the Terrapinn Basel Biology Festival 2020. The department hope to convert 100% of patients by January 15, 2021. From a U.S. perspective, these are a commendable achievement and goal. British Columbia started a similar campaign 6 months earlier than Alberta and have also reported good results. Officials said they were able to fund millions of dollars in savings back to medical programs to expand access to the province’s residents. Other reports in Canada are considering modification programs to achieve similar results. In August, biosimilars had an 8% use share compared to reference drugs in Canada, vs. rates of 50% to 95% for countries that have fully embraced these other biologics.
December
A well-read article in December related to pegfilgrastim biosimilars, whose market share and usage has seen some erosion due to the availability of body injections (OBIs), which have the exclusive marketing for the original brand, Neulasta. OBIs offer convenience but are not 100% reliable, and providers and patients may prefer to use pegfilgrastim biosimilars instead, even if they require patients to return to the clinic for injection. the OBIs automatically at the patient’s home. Studies presented at the Annual Meeting and Exhibition of the American Society of Hematology showed that the failure rate of OBIs contributes to hospital costs. The savings from pegfilgrastim biosimilars, the authors, could significantly extend access to this medication, which is used to reduce febrile neutropenia in patients receiving chemotherapy.
During December, Boehringer Ingelheim (BI) drew attention by filtering a citizen petition calling on the FDA to reconsider the definition of “shape strength” for biosimilars under the Public Health Service Act. The company wants the FDA to define strength to mean “total drug content” regardless of concentration or total dosage. BI argues that startups seeking to prevent biosimilars from challenging their market segment could place undue pressure on the FDA’s current strength definition, which could bequeathing another bios that is actually identical to the reference result.
Finally, new FDA guidance on licensing procedures for biosimilars has emerged when it comes to translating large numbers of clicks from readers Center for Biosimilars®. The FDA asked applicants to be clear during the application process whether they were seeking interchangeable status for their other bios applicants. The guidance was only in draft form and the FDA is accepting comments through January 19, 2021.