Category World News

Gen Z protesters in Mexico are demanding an end to impunity for gang violence and calling for justice for the mayor of Uruapan, Carlos Manzo, who was assassinated at a Day of the Dead event on November 1.

Lowering the prices of prescription drugs has been high on United States President Donald Trump’s agenda since he took office in January. He has taken a number of steps, including striking deals with pharmaceutical companies, to lower the costs of prescription drugs.

Trump has also directed the Food and Drug Administration (FDA) to streamline its regulation process to boost cheaper copycat drugs, such as generic and biosimilar drugs.

Biosimilars are highly similar versions of biologics, a group of drugs produced through biological processes. One of the most widely used biologic drugs is insulin, which is used to treat diabetes.

Biologics, which make up just 5 percent of prescriptions, account for more than half of the total expenditures on medicines in the US, according to the health data analysis company IQVIA.

The Trump administration said it hopes to make these medications more affordable, partly by increasing access to biosimilars.

So what are biologics and biosimilars, and will the administration’s proposals help drive down their costs?

What are biologics?

Biologics is short for biological medications or products. It’s a broad category of products that include vaccines, blood and blood components, gene therapy and tissues. They are a class of complex drugs produced through biological processes or from living organisms, such as proteins and genes. They treat cancer, autoimmune diseases and other rare disorders.

Biologics are typically administered by injection or through an intravenous infusion, said Alex Keeton, executive director of the Biosimilars Council at the Association for Accessible Medicines, an industry group that advocates on behalf of biosimilar manufacturers.

The FDA approval process for these products is rigorous and typically takes 10 to 15 years, said Brian Chen, a University of South Carolina health law and economics expert. Speedier timelines are possible in extraordinary circumstances: Federal agencies worked with vaccine manufacturers and scientists to expedite COVID-19 vaccines, for example.

What are biosimilars?

As the name suggests, these medications are similar to the original biologics approved by the FDA. Biosimilars are developed and sold after the original biologic has lost its patent exclusivity, Keeton said. Biosimilars for Humira, a drug used by people with rheumatoid arthritis, include Cyltezo, Amjevita and Idacio.

“They still work the same way clinically, but they’re not exactly the same,” Keeton said.

That’s because, unlike with generic versions of brand name drugs, it’s impossible to make exact copies of biologics. Biologics have complicated production processes and their components are derived from live organisms.

“Biologics are like strands of flexible, cooked spaghetti folded in very specific ways, making exact replication nearly impossible,” Chen said.

The FDA evaluates proposed biosimilar products against the original biologic to determine whether the product is extremely similar and has no meaningful clinical differences. It is expected to have the same benefits and risks as the original biologic. To be approved, biosimilar manufacturers must show patients using their products don’t have new or worsening side effects compared with patients using the original biologic.

FDA approval for biosimilars often takes five to six years, Keeton said.

Biosimilars increase market competition, incentivising brand name drug manufacturers to lower their prices.

How much do biologics and biosimilars usually cost?

They’re pricey, and exact costs vary.

One 2018 study found that biologics and biosimilars can cost a US patient $10,000 to $30,000 each year on average.

Humira is more. It was listed at $6,922 for a month’s supply in early November. The Humira biosimilar Cyltezo advertises for 5 percent off Humira’s cost. The makers of Cyltezo also offer a non-brand name option for people who pay cash at pharmacies while using the GoodRx app at a price of $550.

The actual amount insured patients pay also depends on their plan and their insurer’s negotiated rates.

Biosimilar prices typically run 15 percent to 35 percent lower than their brand name biologic counterparts, one 2024 study found. The FDA found biologics produce a more dramatic cost savings of 50 percent on average.

Why are these medications so expensive?

Biologics and biosimilars are difficult to develop and produce, which adds to their expense.

Making a standard over-the-counter medication such as aspirin requires five ingredients. Making insulin, a biologic, requires genetic modifications to living organisms.

These complex manufacturing procedures and proprietary information make it difficult for competitors to create alternatives.

To put this in perspective, there were 226 marketed biologics in the US as of July, and the FDA had approved 76 biosimilars such as insulin. When it comes to non-biologic medications, the FDA has approved more than 32,000 generic drugs. That’s more than the number of approved brand name drugs.

Can biosimilars be used in place of the original, FDA-approved biologics?

Yes. All biosimilars must meet FDA requirements and must be highly similar and have no clinically meaningful differences from their existing FDA-approved biologic counterpart.

So how does the Trump administration hope to change the FDA approval process for biosimilars?

Under its draft guidance, the administration proposed reducing some of the tests required as part of the FDA process used to prove a biosimilar drug is as safe and effective as its biologic counterpart.

Currently, a manufacturer requesting a biosimilar licence has to provide clinical study data proving its product’s similarity. The FDA’s new proposal would no longer require drug developers to conduct these comparative clinical trials.

Manufacturers would still be required to test proposed biosimilars. Other data – including comparative analysis, immune response data and human study data showing how the drug moves through the body – could sufficiently demonstrate the drug’s similarity to an existing biologic, the FDA said.

Why does the FDA want to change the biosimilar approval process?

Ultimately, the agency said it aims to incentivise drug manufacturers to quickly develop biosimilars by eliminating redundant, costly and time-consuming clinical studies, Keeton said.

Saving that time might increase the number of biosimilar alternatives.

It would almost certainly lower the front-end development costs for drugmakers, Chen said.

Will that change lower the costs of these medications for patients who need them?

Regulatory changes alone may not significantly drive down prices for many Americans.

Several non-brand name options need to be available to produce significant price drops, according to a US Department of Health and Human Services report.

But prices could remain the same even with more options.

A 2024 study in the JAMA Health Forum, a health policy journal, found that annual out-of-pocket costs either increased or remained stable for most biologics even after biosimilars were available. Patients who used biosimilars didn’t pay less than those who used the original biologics.

That’s at least partly because biologic manufacturers often offer substantial rebates to pharmacy benefit managers, companies that work with insurers, employers and others to manage prescription drug plan benefits. In exchange, insurers give the name brand biologics preferred or exclusive placement on their lists of insurance-covered drugs, Chen said. Rebate walls ultimately prevent the sale of cheaper biosimilars, he said.

Are there any other obstacles to getting more biosimilars on the market?

Yes, another key hurdle remains: Name brand biologic manufacturers often hold many patents and file lawsuits blocking approved biosimilars from being commercially marketed.

A 2018 study conducted by Chen found that of 12 FDA-approved biosimilar products, five were commercially available as of October 2018. Six others were unavailable because of patent disputes.

Palestinian and Lebanese detainees being held in an underground Israeli jail face horrific mistreatment, according to lawyers speaking to Al Jazeera.

In the quiet of his Ramallah studio in the occupied West Bank, Palestinian artist Nabil Anani works diligently on artworks deeply rooted in a movement he helped create during the political tumult of the late 1980s.

Cofounded in 1987 by Anani and fellow artists Sliman Mansour, Vera Tamari and Tayseer Barakat, the New Visions art movement focused on using local natural materials while eschewing Israeli supplies as a form of cultural resistance. The movement prioritised self-sufficiency at a time of deep political upheaval across occupied Palestine.

“[New Visions] emerged as a response to the conditions of the Intifada,” Anani said. “Ideas like boycott and self-reliance inspired a shift in our artistic practice at the time.”

Each of the founding members chose to work with a specific material, developing new artistic styles that fit the spirit of the time. The idea caught on, and many exhibitions followed locally, regionally and internationally.

Nearly four decades later, the principles of New Visions – self-sufficiency, resistance and creation despite scarcity – continue to shape a new generation of Palestinian artists for whom making art is both an expression and an act of survival.

Anani, now 82, and the other founding members are helping keep the movement’s legacy alive.

Why ‘New Visions’?

“We called it New Visions because, at its core, the movement embraced experimentation, especially through the use of local materials,” Anani said, noting how he had discovered the richness of sheepskins, their textures and tones and began integrating them into his art in evocative ways.

In 2002, Tamari, now 80, started planting ceramic olive trees for every real one an Israeli settler burned down to form a sculptural installation called Tale of a Tree. Later, she layered watercolours over ceramic pieces, mediums that usually do not mix, defying the usual limits of each material, and melded in elements of family photos, local landscapes and politics.

Sixty-six-year-old Barakat, meanwhile, created his own pigments and then began burning forms into wood, transforming surface damage into a visual language.

“Other artists began to embrace earth, leather, natural dyes – even the brokenness of materials as part of the story,” Mansour, 78, said, adding that he had personally reached a kind of “dead end” with his work before the New Visions movement emerged, spending years creating works centred around national symbols and identity that had started to feel repetitive.

“This was different. I remember being anxious at first, worried about the cracks in the clay I was using,” he said, referring to his use of mud. “But, in time, I saw the symbolism in those cracks. They carried something honest and powerful.”

In 2006, the group helped create the International Academy of Art Palestine in Ramallah, which was open for 10 years before being integrated into Birzeit University as the Faculty of Art, Music and Design. The academy’s main goal was to help artists transition from older ways of thinking to more contemporary approaches, particularly by using local and diverse materials.

“A new generation emerged from this, raised on these ideas, and went on to hold numerous exhibitions, both locally and internationally, all influenced by the New Visions movement,” Anani said.

A legacy maintained but tested

The work of Lara Salous, a 36-year-old Palestinian artist and designer based in Ramallah, echoes the founding principles of the movement.

“I am inspired by [the movement’s] collective mission. My insistence on using local materials comes from my belief that we must liberate and decolonise our economy.”

“We need to rely on our natural resources and production, go back to the land, boycott Israeli products and support our local industries,” Salous said.

Through Woolwoman, her social enterprise, Salous works with local materials and a community of shepherds, wool weavers and carpenters to create contemporary furniture, like wool and loom chairs, inspired by ancient Bedouin techniques.

But challenges like the increasing number of roadblocks and escalating settler violence against Palestinian Bedouin communities, who rely on sheep grazing as a basic source of income, have made working and living as an artist in the West Bank increasingly difficult.

“I collaborate with shepherds and women who spin wool in al-Auja and Masafer Yatta,” said Salous, referring to two rural West Bank areas facing intense pressure from occupation and settlement expansion.

“These communities face daily confrontations with Israeli settlers who often target their sheep, prevent grazing, cut off water sources like the al-Auja Spring, demolish wells and even steal livestock,” she added.

In July, the Reuters news agency reported an incident in the West Bank’s Jordan Valley, where settlers killed 117 sheep and stole hundreds of others in an overnight attack on one such community.

Such danger leaves Palestinian women who depend on Woolwoman for their livelihoods vulnerable. Several female weavers working with Salous and supporting her enterprise have become their families’ sole breadwinners, especially after their spouses lost jobs due to Israeli work permit bans following the Hamas-led attacks on southern Israel on October 7, 2023, and the start of the Gaza war.

Visiting the communities where these wool suppliers live has become nearly impossible for Salous, who fears attacks by Israeli settlers.

Meanwhile, her collaborators must often prioritise their own safety and the protection of their villages, which disrupts their ability to produce wool to sustain their livelihoods.

As a result, the designer has faced delays and supply chain issues, making completing and selling her works increasingly difficult.

Anani faces similar challenges in procuring hides.

“Even in cities like Ramallah or Bethlehem, where the situation might be slightly more stable, there are serious difficulties, especially in accessing materials and moving around,” he said.

“I work with sheepskin, but getting it from Hebron is extremely difficult due to roadblocks and movement restrictions.”

Creating vs surviving

In Gaza, Hussein al-Jerjawi, an 18-year-old artist from the Remal neighbourhood of Gaza City, is also inspired by the New Visions movement’s legacy and meaning, noting that Mansour’s “style in expressing the [conditions of the occupation]” has inspired him.

Due to a lack of materials like canvases, which are scarce and expensive, al-Jerjawi has repurposed flour bags distributed by the United Nations agency for Palestinian refugees (UNRWA) as canvases for creating his artwork, using wall paint or simple pens and pencils to create portraits of the world around him.

In July, however, the artist said flour bags were no longer available due to Israel’s blockade of food and aid into the Gaza Strip.

“There are no flour bags in Gaza, but I’m still considering buying empty bags to complete my drawings,” he said.

Gaza-born artist Hazem Harb, who now lives in Dubai, also credits the New Visions movement as a constant source of inspiration throughout his decades-long career.

“The New Visions movement encourages artists to push boundaries and challenge conventional forms, and I strive to embody this spirit in my work,” he said while noting that it has been challenging to source the materials from Gaza that he needs for his work.

“The ongoing occupation often disrupts supply chains, making it difficult to obtain the necessary materials for my work. I often relied on local resources and found objects, creatively repurposing materials to convey my message.”

Anani, who said the conditions in Gaza make it nearly impossible to access local material, added that many artists are struggling but still strive to make art with whatever they can.

“I believe artists [in Gaza] are using whatever’s available – burned objects, sand, basic things from their environment,” Anani said.

“Still, they are continuing to create in simple ways that reflect this harsh moment.”