Category Archives: Biosimilars

Risankizumab approval could strengthen AbbVie’s market position

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According to GlobalData, if approved, risankizumab would further strengthen AbbVie’s position in the psoriasis market.

If European approval is granted for AbbVie’s risankizumab for moderate-to-severe plaque psoriasis, the company could further strengthen its position in the psoriasis market, according to GlobalData, a leading data and analytics company.

In 2017, AbbVie reported that Humira (adalimumab), an anti-tumour necrosis factor (TNF) biologic indicated for multiple immunological disorders including psoriasis, generated global sales of $18.42 billion, accounting for 65% of AbbVie’s total net revenue.

Risankizumab is an investigational compound that has been designed by AbbVie to selectively inhibit IL-23 by binding to its subunit p19. AbbVie has submitted a marketing authorisation application (MAA) for risankizumab to the European Medicines Agency (EMA).

Vikesh Devlia, Pharma Analyst at GlobalData, said: “With the anticipated launch of Humira biosimilars in the EU starting from October 2018, AbbVie’s position is threatened in the psoriasis market by both biosimilar erosion and other major pharma companies gaining approval for their IL-17 and IL-23 biologics.”

“This may not affect AbbVie immediately, since physicians will likely continue to prescribe Humira as one of their first-line biologic therapies for moderate-to-severe psoriatic patients. However, the less frequent dosing of IL-17 and IL-23 biologics could shift physicians to opt for these therapeutics eventually.”

“Despite these challenges, AbbVie intends to remain a player within the changing field of psoriasis treatment. With the submission of an MAA for risankizumab, the company could be closer to retaining a strong position in the psoriasis space.”

The currently approved IL-23 inhibitors for psoriasis include Johnson and Johnson’s Tremfya (guselkumab) and Sun Pharma’s Ilumya (tildrakizumab).

Both Tremfya and Ilumya have been shown to have high efficacy in moderate-to-severe psoriasis.

Devlia added: “Although there are not yet any head-to-head trials comparing the efficacy of these drugs to one another, it is clear from Phase III trials that risankizumab and Tremfya will compete for best-in-class status, as both IL-23 drugs deliver high efficacy for moderate-to-severe psoriasis patients.”

SOURCE: www.manufacturingchemist.com/news

Launch of first breast cancer biosimilar in the UK

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MSD has announced the launch of Ontruzant®, (trastuzumab), a biosimilar referencing Herceptin® (trastuzumab/TRZ), for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.

This was the first trastuzumab biosimilar to receive regulatory approval in Europe and is the first to launch in the UK.

Biosimilar trastuzumab represents the first product approved in the UK under a global biosimilars development and commercialisation agreement between MSD and Samsung Bioepis Co Ltd.

The European Medicines Agency (EMA) requires biosimilars to show they are highly similar to the reference medicine in terms of structure, biological activity and efficacy, safety and immunogenicity profile. Ontruzant (trastuzumab biosimilar (SB3)) is a monoclonal antibody and has been shown to have similar safety and efficacy as its reference product Herceptin (TRZ) in early breast cancer, with breast pathologic complete response rates (bpCR) being 51.7% and 42.0% with SB3 and TRZ respectively. The adjusted ratio of bpCR was 1.259 (95%CI, 1.085 to 1.460), which was within the predefined equivalence margins. The adjusted difference was 10.70% (95% CI, 4.13% to 17.26%), with the lower limit contained within and the upper limit outside the equivalence margin. The overall response rates were 96.3% and 91.2% with SB3 and TRZ.

Dr Mark Verrill, Head of the Department of Medical Oncology at the Newcastle upon Tyne Hospitals NHS Foundation Trust, and the deputy lead clinician for breast cancer in the North of England Cancer Network said, “This is good news for so many cancer patients and the NHS. The launch of biosimilar trastuzumab provides a high-quality treatment alternative for patients, while offering significant potential savings for the NHS. The biggest category of medicines in oncology is monoclonal antibodies and the introduction of biosimilars such as trastuzumab could provide a substantial cost saving.”

Denise Blake, Senior Lead Clinical Pharmacist at Newcastle Hospitals, explains, “The introduction of biosimilar trastuzumab provides an opportunity for the NHS to realise substantial financial savings without compromising patient care. Close collaboration between oncologists, pharmacists and nursing staff is required to ensure a seamless introduction into routine clinical practice.”

“As a company committed to inventing new treatment options for both common and neglected types of cancer, MSD is also pleased to be offering the NHS a biosimilar medicine in an established area of care. Biosimilar trastuzumab marks a significant milestone for both MSD and the oncology community, providing the UK’s first biosimilar trastuzumab, based on our collaboration with Samsung Bioepis,”explains Louise Houson, UK Managing Director, MSD.

Regulatory approval was based on a Phase III study that compared SB3 with reference TRZ in patients with human epidermal growth factor receptor HER-2 positive early breast cancer in the neoadjuvant setting.

The study showed the total pathologic complete response rates were 45.8% and 35.8% and the overall response rates were 96.3% and 91.2% with SB3 and TRZ, respectively. Eight hundred patients were included in the per-protocol set (SB3, n = 402; TRZ, n = 398). The bpCR rates were 51.7% and 42.0% with SB3 and TRZ, respectively. The adjusted ratio of bpCR was 1.259 (95%CI, 1.085 to 1.460), which was within the predefined equivalence margins. The adjusted difference was 10.70% (95% CI, 4.13% to 17.26%), with the lower limit contained within pre-specified equivalence margins and the upper limit of the confidence interval slightly exceeding the pre-specified equivalence margins (-13%, 13%).

Overall, 96.6% and 95.2% of patients experienced one or more adverse event, 10.5% and 10.7% had a serious adverse event, and 0.7% and 0.0% had antidrug antibodies (up to cycle 9) with SB3 and TRZ, respectively.

SOURCE: www.hospitalhealthcare.com

The FDA commissioner just laid out how ‘everybody wins’ in the US healthcare system except the patients

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  • FDA Commissioner Dr. Scott Gottlieb put the pressure on health insurance companies and pharma middlemen about the high drug prices patients are facing at a health insurance conference on Wednesday. 
  • “Sick people aren’t supposed to be subsidizing the healthy,” Gottlieb said. “That’s exactly the opposite of what most people thought they were buying when they bought into the notion of having insurance.”
  • Gottlieb’s interested in making the market for biosimilars — essentially generic versions of biologic drugs that could save the US billions — more competitive, something that has proven challenging so far. 

FDA Commissioner Dr. Scott Gottlieb has health insurers in his crosshairs.

Speaking at a policy conference hosted by America’s Health Insurance Plans, the lobby that represents health insurers, Gottlieb called out the practices insurers and pharmaceutical middlemen use that keep prices high for patients.

The Food and Drug Administration, which Gottlieb oversees, is responsible for regulating food and drugs, as well as medical devices, blood donations, veterinary products, cosmetics, and tobacco. While he has oversight into whether or not a drug is approved, the agency does not play a role in determining how much the medication costs once it’s on the market.

Even so, he did not mince words when it came to pointing out the shortcomings of the way those prescriptions get paid for.

“The top three PBMs control more than two-thirds of the market; the top three wholesalers more than 80%; and the top five pharmacies more than 50%,” he said, referring to pharmacy benefits managers, which negotiate lower prices for brand-name medications. “Market concentration may prevent optimal competition. And so the saving may not always be passed along to employers or consumers.”

That’s putting pressure on patients when they show up at the pharmacy counter.

“We continue to see a backlash against these Kabuki drug-pricing constructs — constructs that obscure profit taking across the supply chain that drives up costs; that expose consumers to high out of pocket spending; and that actively discourage competition.”

That can lead to those with chronic conditions paying more for their medication, often close to the list price if they have a high deductible health plan that leaves them on the hook for paying a certain amount before insurance kicks in. And because the rebates drug companies pay to insurers and middlemen are still getting paid, that cost gets absorbed into lowering premiums for everyone who’s insured, healthy and sick alike.

“Sick people aren’t supposed to be subsidizing the healthy,” he said. “That’s exactly the opposite of what most people thought they were buying when the bought into the notion of having insurance.”

The insurers and the pharmaceutical middlemen need to own their role in the pressure it’s putting on patients, Gottlieb said.

“Now I understand that there’s a perverse incentive to use that rebated money to lower premium costs, since most health plans compete on the sticker cost of their premiums,” he said. “But we’re living in a world where financial toxicity is a real concern for patients. And every member of the drug supply chain needs to take responsibility for addressing it.”

Gottlieb’s bringing this responsibility up due to his interest in making the market for biosimilars — essentially generic versions of biologic drugs that could save the US billions — more competitive, something that has proven challenging so far.

Because of how rebates get paid out, there’s not a lot of incentive to use a cheaper version of the biologic drug, which keeps costs high.

“Everybody wins. The health plans get the big rebates. The PBMs get paid on these spreads. And branded sponsors hold onto market share,” he said. “Everyone that is, but the patients, who in the long run, don’t benefit from the full value of increased competition Congress intended.”

On Tuesday, the biggest health insurer in the US, UnitedHealthcare, said that starting in 2019, some of its members on high deductible plans would be eligible to get rebates for their medications. So, for example, if a patient went to the pharmacy for a medication that under their high deductible cost $600, that might get lowered to $300 after factoring in the rebate the insurer receives. Gottlieb called the move a “potentially disruptive step.”

“This could make the difference between patients affording their medicines and remaining adherent, or stopping effective therapy to save on out of pocket costs,” he said.

“Payors are going to have to decide what they want: The short-term profit goose that comes with the rebates, or in the long run, a system that functions better for patients, providers, and those who pay for care.”

SOURCE: www.http://uk.businessinsider.com