Why is biosimilar adoption slow in the U.S., and can something be done to boost uptake?

ALARIC DEARMENT | October 1, 2019 | 161 views

Since the Hatch-Waxman Act of 1984 created an abbreviated regulatory approval pathway for generic pharmaceutical drugs in the U.S., generics have made tremendous strides in bringing down the cost of many medical treatments and even come to dominate some therapeutic areas.

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Quick'rCare

Quick’rCare is the better immediate healthcare experience for every patient. Started in 2016, we’ve worked to fix the broken systems that get in the way of good immediate care by uniting modern patients and providers. It all started when our founder was trying to give some advice to a friend to go to an immediate care facility, but neither one of them knew where to go. So they searched online and asked friend close by, but they got all kinds of answer like the hospital, the local walk in clinic, and even to go home to mom! So this founder’s friend decided to walk into the hospital hours later and came out with huge bill. From there, the light bulb went off and Quick’rCare was born.

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PHARMA TECH

Tips for Managing Chronic Pain Beyond Prescription Painkillers

Article | September 29, 2022

Painkillers like Oxycontin, Percocet, and Vicodin, have been prescribed by primary physicians, surgeons, dentists, and other healthcare providers to patients suffering from varying levels of pain. Though these medications have proven to be an effective source of pain relief, they have also proven to be highly addictive. In fact, it has even been reported that there are more cases of a drug overdose and deaths from prescription painkillers than heroin or cocaine. While there are a number of factors that play into this opioid epidemic, educating doctors and patients on alternative solutions to managing chronic pain is a great place to start combatting this nationwide crisis.

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PHARMA TECH

What are the advantages of PCD Pharma Company?

Article | July 15, 2022

PCD Pharma stands for propaganda distribution. A PCD company gives brand name and support to its franchises. They also provide distribution rights and monopoly rights within a particular region. If a person wants to establish their business, it is a must for them to know the pros and cons of the business to make a sound decision. Needless to mention that PCD company has a lot to contribute in the medical filed. Worldwide in a medical field, A PCD Pharma Company is playing an essential and crucial role in the rapid growth. The pharma industry is progressing t a fast pace. The company uses the latest technologies for each brand which ensures the safety of products and accepts the responsibility of human health & life by providing better outcomes. To have a drug license number and company registration, the cost to establish the company is quite cost-effective that is15000-20000rs. So this gives people a brilliant opportunity to have their unit without digging a big hole in their bank balance. Indian produces exquisite quality products, which make pharma companies a considerable success.

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PHARMA TECH

WALGREEN’S IN HOT WATER OVER PHONY PHARMACIST

Article | July 13, 2022

The drugstore chain agreed to pay $7.5 million in fines after an unlicensed pharmacist at several San Francisco Bay locations illegally filled more than 700,000 prescriptions over a ten-year period. According to California prosecutors, Kim Thien Le stole license numbers from other pharmacists to fill prescriptions for Fentanyl, morphine, and other painkillers. Le pleaded guilty to multiple felony impersonation counts. Walgreen’s agreed to the settlement to avoid being charged with consumer fraud in Alameda and Santa Anna Counties. Prosecutors alleged that Walgreen’s failed to verify Le’s license and did not conduct a thorough background check. The company insisted it has taken remedial measures.

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How Can Medical Cannabis Help to Manage Pain Conditions? – The Cannabis Exchange

Article | February 11, 2020

Pain management is one of the most common reasons for the use of medical cannabis products. However, despite many jurisdictions – including Canada, Germany, and the Netherlands – now allowing the prescription of medical cannabis for this purpose, there remains little ‘high-quality’ evidence to support, or oppose its efficacy. Madden et al. (2018) set out to review the evidence available in order to determine the efficacy of medical cannabis when employed in the management of various forms of musculoskeletal pain. The researchers analysed various studies that assessed the use of cannabinoids in the treatment of arthritis pain; back pain; postoperative pain; and trauma-related pain. It is estimated that up to 30% of the population may suffer from a non-cancer-related pain condition. As such a high percentage of people suffer from these conditions, the development of simple and safe therapies is an essential area of research. This is particularly important as the therapeutic options for people with chronic pain are increasingly limited.

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Spotlight

Quick'rCare

Quick’rCare is the better immediate healthcare experience for every patient. Started in 2016, we’ve worked to fix the broken systems that get in the way of good immediate care by uniting modern patients and providers. It all started when our founder was trying to give some advice to a friend to go to an immediate care facility, but neither one of them knew where to go. So they searched online and asked friend close by, but they got all kinds of answer like the hospital, the local walk in clinic, and even to go home to mom! So this founder’s friend decided to walk into the hospital hours later and came out with huge bill. From there, the light bulb went off and Quick’rCare was born.

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PHARMA TECH

AstraZeneca, Daiichi Sankyo push Enhertu closer to the blockbuster frontier with stomach cancer

Daiichi | January 20, 2021

Daiichi Sankyo and partner AstraZeneca have taken their HER2-targeted cancer drug Enhertu another step toward blockbusterland. The FDA cleared Enhertu for HER2-positive gastric or gastroesophageal junction cancer patients who previously received Roche’s standard-of-care Herceptin, the companies said Monday. An antibody-drug conjugate, Enhertu is the first HER2-directed therapy approved in gastric cancer in a decade, the companies said. And it earned the green light after showing—for the first time in this patient population—that an HER2 drug could top chemotherapy at helping patients live significantly longer. In the pivotal Destiny-Gastric01 trial in Japan and South Korea, Enhertu cut the risk of death by 41% versus chemotherapy in patients who had progressed on at least two previous treatments, including Herceptin. At an interim analysis, patients on Enhertu had lived a median 12.5 months, versus 8.4 months with chemotherapy, according to data presented at the 2020 American Society of Clinical Oncology (ASCO) meeting. On the study’s primary endpoint of overall response rate, Enhertu shrank tumors in 40.5% of patients, compared with a response rate of 11.3% in the chemo arm. Previously treated HER2-positive stomach cancer now becomes Enhertu’s second U.S. approval, on top of its original nod in third-line HER2-positive breast cancer. Both Daiichi and AZ are banking their oncology revenue growth on Enhertu. Daiichi’s in the middle of a transformation that puts oncology front and center as the Japanese pharma pivots away from the cardiovascular and metabolic fields. As part of the overhaul, the company’s targeting JPY500 billion ($5 billion) in peak oncology drug sales. Enhertu could take about half of that load: It now bears a 2024 sales estimate of around $2.5 billion, with some bullish industry watchers projecting peak sales above $4 billion.

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PHARMA TECH

BeiGene-Novartis PD-1 deal; Sinovac vaccine; Celltrion antibody COVID-19 data

Novartis | January 19, 2021

Novartis plunked down up to $2.2 billion for BeiGene's China-approved PD-1 drug tislelizumab to complement its own checkpoint inhibitor. Hear what BeiGene CEO John Oyler has to say about tislelizumab's position in and outside China. Sinovac's COVID-19 vaccine reported confusing data from Brazil, raising doubt about its true efficacy. Celltron's anti-SARS-CoV-2 antibody improved patients' outcomes in a phase 2/3 trial. And more. Novartis paid $650 million upfront and committed up to $1.55 billion in milestones to license certain rights to BeiGene’s PD-1 inhibitor tislelizumab in major markets outside China. The Swiss pharma is not abandoning its own checkpoint inhibitor spartalizumab despite a recent phase 3 trial failure; instead, it views the two PD-1s as “complementary.” BeiGene retains the right to co-market tislelizumab in North America. The Novartis deal gives the Chinese biotech a chance to get help “learning how to commercialize and build some capabilities” beyond China, BeiGene CEO John Oyler said in an interview. He believes the drug could compete in Asian-prevalent cancer types and its value in large indications will show over time. The CEO also believes the PD-1/L1 class has reached a pricing sweet spot in China where additional major price cuts aren’t likely. Brazilian researchers first said Sinovac’s COVID-19 vaccine, CoronaVac, was 78% effective in a local phase 3 trial. But then, a few days ago, they released new data of just 50.4% efficacy. The gap was caused by the omission of “very mild” infections in the previous data. The misstep led to criticism of the trial organization, Brazil’s Butantan biomedical center, as well as suspicion about CoronaVac’s true efficacy. Turkey just authorized the shot for emergency use based on a reported 91.25% efficacy in an interim analysis of its local trial.

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PHARMA TECH

CareRx Applauds Ontario Ministry of Health's Pause of Planned Fee Changes

CareRx | January 18, 2021

CareRx Corporation ("CareRx" or the "Company") (TSX: CRRX), Canada's leading provider of specialty pharmacy services to seniors, is pleased that the Ontario Ministry of Health has announced that it will pause for one year previously scheduled changes to long-term care pharmacy funding, which were scheduled to go into effect on April 1, 2021. Under certain amendments to the Ontario Drug Benefit Act that came into effect on January 1, 2020, the reimbursement model for long-term care pharmacies in Ontario was changed from a fee-for-service model to a fee-per-bed capitation model under which pharmacies receive a fixed professional fee for all pharmacy services provided to residents in long-term care homes. The fee for 2020, which was prescribed at $1,500, was scheduled to decline to $1,400 per bed serviced on April 1, 2021. The step-down in capitation has now been paused until April 1, 2022. "Long-term care homes and their staff have faced unprecedented challenges during COVID-19," said David Murphy, President and Chief Executive Officer of CareRx. "This pause will ensure that pharmacies like CareRx can continue to deliver the same exceptional partnership and service offering to long-term care homes and help alleviate the burden COVID-19 has placed on home staff. We want to thank Minister Elliott, Minister Fullerton and the Ontario Government for their ongoing dialogue and commitment to protecting the wellbeing of residents in long-term care." About CareRx Corporation CareRx is Canada's leading provider of specialty pharmacy services to seniors. We serve approximately 50,000 residents in over 900 seniors and other communities (long-term care homes, retirement homes, assisted living facilities, and group homes). We are a national organization with a large network of pharmacy fulfillment centres strategically located across the country. This allows us to deliver medications in a timely and cost-effective manner and quickly respond to routine changes in medication management. We use best-in-class technology that automates the preparation and verification of multi-dose compliance packaging of medication, providing the highest levels of safety and adherence for individuals with complex medication regimes. We take an active role in working with our home operator partners to promote resident health, staff education, and medication system quality and efficiency.

Read More

PHARMA TECH

AstraZeneca, Daiichi Sankyo push Enhertu closer to the blockbuster frontier with stomach cancer

Daiichi | January 20, 2021

Daiichi Sankyo and partner AstraZeneca have taken their HER2-targeted cancer drug Enhertu another step toward blockbusterland. The FDA cleared Enhertu for HER2-positive gastric or gastroesophageal junction cancer patients who previously received Roche’s standard-of-care Herceptin, the companies said Monday. An antibody-drug conjugate, Enhertu is the first HER2-directed therapy approved in gastric cancer in a decade, the companies said. And it earned the green light after showing—for the first time in this patient population—that an HER2 drug could top chemotherapy at helping patients live significantly longer. In the pivotal Destiny-Gastric01 trial in Japan and South Korea, Enhertu cut the risk of death by 41% versus chemotherapy in patients who had progressed on at least two previous treatments, including Herceptin. At an interim analysis, patients on Enhertu had lived a median 12.5 months, versus 8.4 months with chemotherapy, according to data presented at the 2020 American Society of Clinical Oncology (ASCO) meeting. On the study’s primary endpoint of overall response rate, Enhertu shrank tumors in 40.5% of patients, compared with a response rate of 11.3% in the chemo arm. Previously treated HER2-positive stomach cancer now becomes Enhertu’s second U.S. approval, on top of its original nod in third-line HER2-positive breast cancer. Both Daiichi and AZ are banking their oncology revenue growth on Enhertu. Daiichi’s in the middle of a transformation that puts oncology front and center as the Japanese pharma pivots away from the cardiovascular and metabolic fields. As part of the overhaul, the company’s targeting JPY500 billion ($5 billion) in peak oncology drug sales. Enhertu could take about half of that load: It now bears a 2024 sales estimate of around $2.5 billion, with some bullish industry watchers projecting peak sales above $4 billion.

Read More

PHARMA TECH

BeiGene-Novartis PD-1 deal; Sinovac vaccine; Celltrion antibody COVID-19 data

Novartis | January 19, 2021

Novartis plunked down up to $2.2 billion for BeiGene's China-approved PD-1 drug tislelizumab to complement its own checkpoint inhibitor. Hear what BeiGene CEO John Oyler has to say about tislelizumab's position in and outside China. Sinovac's COVID-19 vaccine reported confusing data from Brazil, raising doubt about its true efficacy. Celltron's anti-SARS-CoV-2 antibody improved patients' outcomes in a phase 2/3 trial. And more. Novartis paid $650 million upfront and committed up to $1.55 billion in milestones to license certain rights to BeiGene’s PD-1 inhibitor tislelizumab in major markets outside China. The Swiss pharma is not abandoning its own checkpoint inhibitor spartalizumab despite a recent phase 3 trial failure; instead, it views the two PD-1s as “complementary.” BeiGene retains the right to co-market tislelizumab in North America. The Novartis deal gives the Chinese biotech a chance to get help “learning how to commercialize and build some capabilities” beyond China, BeiGene CEO John Oyler said in an interview. He believes the drug could compete in Asian-prevalent cancer types and its value in large indications will show over time. The CEO also believes the PD-1/L1 class has reached a pricing sweet spot in China where additional major price cuts aren’t likely. Brazilian researchers first said Sinovac’s COVID-19 vaccine, CoronaVac, was 78% effective in a local phase 3 trial. But then, a few days ago, they released new data of just 50.4% efficacy. The gap was caused by the omission of “very mild” infections in the previous data. The misstep led to criticism of the trial organization, Brazil’s Butantan biomedical center, as well as suspicion about CoronaVac’s true efficacy. Turkey just authorized the shot for emergency use based on a reported 91.25% efficacy in an interim analysis of its local trial.

Read More

PHARMA TECH

CareRx Applauds Ontario Ministry of Health's Pause of Planned Fee Changes

CareRx | January 18, 2021

CareRx Corporation ("CareRx" or the "Company") (TSX: CRRX), Canada's leading provider of specialty pharmacy services to seniors, is pleased that the Ontario Ministry of Health has announced that it will pause for one year previously scheduled changes to long-term care pharmacy funding, which were scheduled to go into effect on April 1, 2021. Under certain amendments to the Ontario Drug Benefit Act that came into effect on January 1, 2020, the reimbursement model for long-term care pharmacies in Ontario was changed from a fee-for-service model to a fee-per-bed capitation model under which pharmacies receive a fixed professional fee for all pharmacy services provided to residents in long-term care homes. The fee for 2020, which was prescribed at $1,500, was scheduled to decline to $1,400 per bed serviced on April 1, 2021. The step-down in capitation has now been paused until April 1, 2022. "Long-term care homes and their staff have faced unprecedented challenges during COVID-19," said David Murphy, President and Chief Executive Officer of CareRx. "This pause will ensure that pharmacies like CareRx can continue to deliver the same exceptional partnership and service offering to long-term care homes and help alleviate the burden COVID-19 has placed on home staff. We want to thank Minister Elliott, Minister Fullerton and the Ontario Government for their ongoing dialogue and commitment to protecting the wellbeing of residents in long-term care." About CareRx Corporation CareRx is Canada's leading provider of specialty pharmacy services to seniors. We serve approximately 50,000 residents in over 900 seniors and other communities (long-term care homes, retirement homes, assisted living facilities, and group homes). We are a national organization with a large network of pharmacy fulfillment centres strategically located across the country. This allows us to deliver medications in a timely and cost-effective manner and quickly respond to routine changes in medication management. We use best-in-class technology that automates the preparation and verification of multi-dose compliance packaging of medication, providing the highest levels of safety and adherence for individuals with complex medication regimes. We take an active role in working with our home operator partners to promote resident health, staff education, and medication system quality and efficiency.

Read More

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